Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT02106403
Status:
COMPLETED
Last Update Posted:
2015-02-11
First Post:
2014-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from the start of the investigational product, and until last visit (7 days following last administration of the investigational product).', 'eventGroups': [{'id': 'EG000', 'title': 'Prototype Disinfectant Spray Formulation', 'description': '0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.', 'otherNumAtRisk': 50, 'otherNumAffected': 1, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Reference Product', 'description': '0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.', 'otherNumAtRisk': 50, 'otherNumAffected': 1, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Negative Control', 'description': '0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.', 'otherNumAtRisk': 50, 'otherNumAffected': 1, 'seriousNumAtRisk': 50, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Itch in all three wounds(Wound Complication)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participant-perceived Cooling Sensation Immediately Post Product Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prototype Disinfectant Spray Formulation', 'description': '0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}, {'id': 'OG001', 'title': 'Reference Product', 'description': '0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}, {'id': 'OG002', 'title': 'Negative Control', 'description': '0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.63', 'spread': '4.345', 'groupId': 'OG000'}, {'value': '30.15', 'spread': '4.345', 'groupId': 'OG001'}, {'value': '25.16', 'spread': '4.345', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0659', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.46', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '11.29', 'estimateComment': 'Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.', 'groupDescription': 'The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.', 'testedNonInferiority': False}, {'pValue': '0.0928', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.99', 'ciLowerLimit': '-0.84', 'ciUpperLimit': '10.81', 'estimateComment': 'Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.', 'groupDescription': 'The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.', 'testedNonInferiority': False}, {'pValue': '0.8711', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.48', 'ciLowerLimit': '-5.35', 'ciUpperLimit': '6.31', 'estimateComment': 'Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.', 'groupDescription': 'The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Immediately after product application', 'description': 'The cooling sensation was assessed immediately after the study product application on 100 millimeter (mm) Visual Analogue Scale (VAS) (0-100 mm, where 0= no cooling and 100= extreme cooling).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population'}, {'type': 'PRIMARY', 'title': 'Participant-perceived Cooling Sensation at 3 Min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prototype Disinfectant Spray Formulation', 'description': '0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}, {'id': 'OG001', 'title': 'Reference Product', 'description': '0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}, {'id': 'OG002', 'title': 'Negative Control', 'description': '0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.15', 'spread': '3.726', 'groupId': 'OG000'}, {'value': '29.42', 'spread': '3.726', 'groupId': 'OG001'}, {'value': '27.73', 'spread': '3.726', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.43', 'ciLowerLimit': '4.43', 'ciUpperLimit': '18.42', 'estimateComment': 'Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.', 'groupDescription': 'The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.', 'testedNonInferiority': False}, {'pValue': '0.6323', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.69', 'ciLowerLimit': '-5.31', 'ciUpperLimit': '8.69', 'estimateComment': 'Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.', 'groupDescription': 'The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.', 'testedNonInferiority': False}, {'pValue': '0.0069', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.73', 'ciLowerLimit': '2.74', 'ciUpperLimit': '16.73', 'estimateComment': 'Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.', 'groupDescription': 'The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 3 min after product application', 'description': 'The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 3 min post study product application.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population'}, {'type': 'PRIMARY', 'title': 'Participant-perceived Cooling Sensation at 5 Min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prototype Disinfectant Spray Formulation', 'description': '0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound'}, {'id': 'OG001', 'title': 'Reference Product', 'description': '0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}, {'id': 'OG002', 'title': 'Negative Control', 'description': '0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.46', 'spread': '3.147', 'groupId': 'OG000'}, {'value': '20.14', 'spread': '3.147', 'groupId': 'OG001'}, {'value': '22.32', 'spread': '3.147', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.13', 'ciLowerLimit': '6.23', 'ciUpperLimit': '18.04', 'estimateComment': 'Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.', 'groupDescription': 'The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.', 'testedNonInferiority': False}, {'pValue': '0.4645', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.18', 'ciLowerLimit': '-8.09', 'ciUpperLimit': '3.72', 'estimateComment': 'Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.', 'groupDescription': 'The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.32', 'ciLowerLimit': '8.41', 'ciUpperLimit': '20.22', 'estimateComment': 'Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.', 'groupDescription': 'The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 5 min after product application', 'description': 'The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 5 min post study product application.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population'}, {'type': 'PRIMARY', 'title': 'Participant-perceived Cooling Sensation at 15 Min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prototype Disinfectant Spray Formulation', 'description': '0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}, {'id': 'OG001', 'title': 'Reference Product', 'description': '0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}, {'id': 'OG002', 'title': 'Negative Control', 'description': '0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.84', 'spread': '2.725', 'groupId': 'OG000'}, {'value': '12.45', 'spread': '2.725', 'groupId': 'OG001'}, {'value': '10.43', 'spread': '2.725', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0357', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.41', 'ciLowerLimit': '0.44', 'ciUpperLimit': '12.38', 'estimateComment': 'Difference was calculated as the prototype disinfectant spray formulation minus negative control such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.', 'groupDescription': 'The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.', 'testedNonInferiority': False}, {'pValue': '0.5030', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.02', 'ciLowerLimit': '-3.95', 'ciUpperLimit': '8.00', 'estimateComment': 'Difference was calculated as the reference product minus negative control such that a positive difference showed improved cooling in the reference product.', 'groupDescription': 'The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.', 'testedNonInferiority': False}, {'pValue': '0.1482', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.39', 'ciLowerLimit': '-1.59', 'ciUpperLimit': '10.36', 'estimateComment': 'Difference was calculated as the prototype disinfectant spray formulation minus reference product such that a positive difference showed improved cooling in the prototype disinfectant spray formulation.', 'groupDescription': 'The null and alternative hypotheses were: H0: product difference was null vs. Ha: product difference was not null.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Calculated from mixed effect ANOVA analysis with treatment and assessment site as fixed effects and subject as random effect.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 15 min after product application', 'description': 'The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 15 min post study product application.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population'}, {'type': 'SECONDARY', 'title': 'Overall Sensory Liking of Study Products', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prototype Disinfectant Spray Formulation', 'description': '0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}, {'id': 'OG001', 'title': 'Reference Product', 'description': '0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}, {'id': 'OG002', 'title': 'Negative Control', 'description': '0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.60', 'spread': '0.199', 'groupId': 'OG000'}, {'value': '6.38', 'spread': '0.199', 'groupId': 'OG001'}, {'value': '6.22', 'spread': '0.199', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Immediatey, 3 min, 5 min and 15 min after product application', 'description': 'Overall sensory liking of the study products was assessed immediately, 3min, 5 min and 15 min after products application. The assessment was done on a 9 point categorical scale where 1= Dislike it extremely, 2= Dislike it very much, 3= Dislike it moderately, 4= Dislike it slightly, 5= Neither like it nor dislike it, 6= Like it slightly, 7= Like it moderately, 8= Like it very much, 9= Like it extremely.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis was based on intent-to-treat (ITT) population defined as all randomized participants who received the product at least once and provided at least one post product use assessment of efficacy. One participant had one efficacy assessment outside the required time window but was included in ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence 1', 'description': 'Prototype disinfectant spray was sprayed twice on first wound, followed by Reference product twice sprayed on the second wound and subsequently Negative control was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.'}, {'id': 'FG001', 'title': 'Sequence 2', 'description': 'Prototype disinfectant spray was sprayed twice on first wound, followed by Negative control sprayed twice on the second wound and subsequently Reference product was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.'}, {'id': 'FG002', 'title': 'Sequence 3', 'description': 'Reference product was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Negative control sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.'}, {'id': 'FG003', 'title': 'Sequence 4', 'description': 'Reference product was sprayed twice on the first wound, followed by Negative control sprayed twice on the second wound and subsequently prototype disinfectant spray was twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.'}, {'id': 'FG004', 'title': 'Sequence 5', 'description': 'Negative control was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Reference product sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.'}, {'id': 'FG005', 'title': 'Sequence 6', 'description': 'Negative control was sprayed twice on the first wound, followed by Reference product sprayed twice on the second wound and Prototype Disinfectant Spray twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.'}], 'periods': [{'title': 'Visit 1, Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Visit 1, Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Visit 1, Treatment Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Follow-Up Visit 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Follow-Up Visit 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Other Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Partcipants were recruited at one clinical study site in China.', 'preAssignmentDetails': 'A total of 50 participants with 1:1 ratio of male to female were screened and 50 were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Randomized Participants', 'description': 'All randomized participants were evaluated for baseline characteristics'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'spread': '12.32', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-26', 'studyFirstSubmitDate': '2014-03-27', 'resultsFirstSubmitDate': '2015-01-26', 'studyFirstSubmitQcDate': '2014-04-03', 'lastUpdatePostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-01-26', 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant-perceived Cooling Sensation Immediately Post Product Application', 'timeFrame': 'Immediately after product application', 'description': 'The cooling sensation was assessed immediately after the study product application on 100 millimeter (mm) Visual Analogue Scale (VAS) (0-100 mm, where 0= no cooling and 100= extreme cooling).'}, {'measure': 'Participant-perceived Cooling Sensation at 3 Min', 'timeFrame': 'At 3 min after product application', 'description': 'The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 3 min post study product application.'}, {'measure': 'Participant-perceived Cooling Sensation at 5 Min', 'timeFrame': 'At 5 min after product application', 'description': 'The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 5 min post study product application.'}, {'measure': 'Participant-perceived Cooling Sensation at 15 Min', 'timeFrame': 'At 15 min after product application', 'description': 'The cooling sensation was assessed on VAS (0-100 mm, where 0= no cooling and 100= extreme cooling) at 15 min post study product application.'}], 'secondaryOutcomes': [{'measure': 'Overall Sensory Liking of Study Products', 'timeFrame': 'Immediatey, 3 min, 5 min and 15 min after product application', 'description': 'Overall sensory liking of the study products was assessed immediately, 3min, 5 min and 15 min after products application. The assessment was done on a 9 point categorical scale where 1= Dislike it extremely, 2= Dislike it very much, 3= Dislike it moderately, 4= Dislike it slightly, 5= Neither like it nor dislike it, 6= Like it slightly, 7= Like it moderately, 8= Like it very much, 9= Like it extremely.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Skin Care']}, 'descriptionModule': {'briefSummary': 'The objective of this randomised, examiner and subject blinded study is to evaluate and compare cooling performance and overall consumer liking of the prototype formulation with the currently marketed wound spray and negative control in subjects with experimental wounds. For each subject, three superficial wounds will be induced on two volar forearms, by sequential tape strippings until a glistening layer is visualized. After wounding, a randomised test product will be sprayed twice on test site, and the subject will be asked to complete a questionnaire evaluating product cooling performance and overall liking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants in good health with healthy and intact skin on the test area\n* Age 18-60 years\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding\n* Allergy/Intolerance\n* Participants currently taking any topical or systemic treatments that may interfere with or mask the test results\n* Participants who have taken any topical anti-inflammation treatment in the application area in past 2 months\n* Participants who are vulnerable to any intervention\n* Damaged skin close to test site, active skin disorders, any visible skin disorder'}, 'identificationModule': {'nctId': 'NCT02106403', 'briefTitle': 'A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study to Evaluate the Cooling Sensation and Consumer Liking of a Skin Disinfectant Spray', 'orgStudyIdInfo': {'id': '202273'}, 'secondaryIdInfos': [{'id': 'RH02332', 'type': 'OTHER', 'domain': 'GSK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prototype disinfectant spray formulation', 'description': '0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound', 'interventionNames': ['Other: Prototype disinfectant spray formulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference product', 'description': '0.13% w/w BAC. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound', 'interventionNames': ['Other: Reference product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Negative control', 'description': '0.9% w/v sodium chloride solution. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound', 'interventionNames': ['Other: Negative control']}], 'interventions': [{'name': 'Prototype disinfectant spray formulation', 'type': 'OTHER', 'description': '0.13% w/w BAC and 1% MGA. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound', 'armGroupLabels': ['Prototype disinfectant spray formulation']}, {'name': 'Reference product', 'type': 'OTHER', 'description': '0.13% w/w BAC. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound', 'armGroupLabels': ['Reference product']}, {'name': 'Negative control', 'type': 'OTHER', 'description': '0.9% w/v sodium chloride solution. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound', 'armGroupLabels': ['Negative control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510635', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangzhou Landproof Testing Technology Co., LTD', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}