Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-06 @ 9:21 PM
Study NCT ID:
NCT02896569
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2016-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tolerability of Using a Post-Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'yoni@venusconcept.com', 'phone': '888-907-0115', 'title': 'Yoni Iger', 'organization': 'Venus Concept Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'The study collected adverse event data for 3 months 4 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Topical Combination Therapy', 'description': 'Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face\n\nTopical combination therapy', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'No topical therapies for 24 hours post-radio-frequency treatment of the face', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 0, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Combination Therapy', 'description': 'Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face\n\nTopical combination therapy'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'No topical therapies for 24 hours post-radio-frequency treatment of the face'}], 'classes': [{'categories': [{'title': 'Tx 1 at 24 hr Very Tolerable', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': 'Tx 1 at 24 hr Tolerable', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Tx 1 at 24 hr Having No Opinion', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Tx 1 at 24 hr InTolerable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Tx 1 at 24 hr Very Intolerable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24hr post treatment one', 'description': 'Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all subjects only responded to telephone request for tolerability at 24 hours'}, {'type': 'PRIMARY', 'title': 'Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Combination Therapy', 'description': 'Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face\n\nTopical combination therapy'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'No topical therapies for 24 hours post-radio-frequency treatment of the face'}], 'classes': [{'categories': [{'title': 'Tx 1 at 72 hr - Very Tolerable', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Tx 1 at 72 hr - Tolerable', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Tx 1 at 72 hr Having No Opinion', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Tx 1 at 72 hr InTolerable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Tx 1 at 72 hr Very Intolerable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72 hrs post treatment one', 'description': 'Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Combination Therapy', 'description': 'Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face\n\nTopical combination therapy'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'No topical therapies for 24 hours post-radio-frequency treatment of the face'}], 'classes': [{'categories': [{'title': 'Tx 2 at 24 hr - Very Tolerable', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'Tx 2 at 24 hr - Tolerable', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Tx 2 at 24 hr Having No Opinion', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Tx 2 at 24 hr InTolerable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Tx 2 at 24 hr Very Intolerable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24hr post treatment two', 'description': 'Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Combination Therapy', 'description': 'Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face\n\nTopical combination therapy'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'No topical therapies for 24 hours post-radio-frequency treatment of the face'}], 'classes': [{'categories': [{'title': 'Tx 2 at 72 hr - Very Tolerable', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Tx 2 at 72 hr - Tolerable', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Tx 2 at 72 hr Having No Opinion', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Tx 2 at 72 hr InTolerable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Tx 2 at 72 hr Very Intolerable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '72hr post treatment two', 'description': 'Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Combination Therapy', 'description': 'Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face\n\nTopical combination therapy'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'No topical therapies for 24 hours post-radio-frequency treatment of the face'}], 'classes': [{'title': 'Treatment 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'title': 'No pain (0 - 0.4cm)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Mild Pain (0.5 - 4.4 cm)', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Moderate Pain (4.5 - 7.4 cm)', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Severe Pain (7.5 - 10 cm)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Treatment 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'title': 'No pain (0 - 0.4cm)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Mild Pain (0.5 - 4.4 cm)', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Moderate Pain (4.5 - 7.4 cm)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Severe Pain (7.5 - 10 cm)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'immediately following radio-frequency treatment', 'description': "10 cm Subject discomfort scale where 10 cm indicates 'Pain as bad as it can be' and 0 cm indicates there is no pain at all associated with the application of the treatment. Zero pain means a better outcome. Subjects were categorized as to having no pain (0 - 0.4cm), mild pain (0.5 - 4.4cm), moderate pain (4.5 - 7.4cm) and severe pain (7.5 - 10cm).", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all subjects reported VAS for each treatment.'}, {'type': 'SECONDARY', 'title': 'Fitzpatrick Wrinkle and Elastosis Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Combination Therapy', 'description': 'Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face\n\nTopical combination therapy'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'No topical therapies for 24 hours post-radio-frequency treatment of the face'}], 'classes': [{'categories': [{'title': 'No change in FWES score', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'FWES score increased by one', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Non-evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'change in appearance of wrinkles from baseline and at end of study, average of 24 days', 'description': 'Investigator assessment of improvement in wrinkles and elastosis where Class I indicates fine wrinkles, Class II indicates fine to moderate depth wrinkles with a moderate number of lines and Class III indicates fine to deep wrinkles, numerous lines with or without redundant skin folds with a score of 1 - 3 (Mild) indicates fine texture changes with subtly accentuated skin lines, a score of 4 - 6 (Moderate) indicates distinct papular elastosis (\\[indvidual papules with yellow translucency under direct lighting\\] and dyschromia and a score of 7 - 9 (Severe) indicates multipapular and confluent elastosis \\[thickened yellow and pallid\\] approaching or consistent with cutis rhomboidalis. A lower class and a lower score means a better outcome. Subjects were divided into 3 categories - No change in FWES score, change in FWES score by one and non-evaluable.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Global Aesthetic Improvement Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical Combination Therapy', 'description': 'Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face\n\nTopical combination therapy'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'No topical therapies for 24 hours post-radio-frequency treatment of the face'}], 'classes': [{'categories': [{'title': 'GAIS Improved', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}, {'title': 'GAIS No Change', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'change in skin appearance between baseline and at end of study, average of 24 days', 'description': 'Investigator assessment of aesthetic improvement where 1 shows exceptional improvement, 2 shows very improved, 3 shows improvement, 4 shows unchanged and 5 indicates that the subject appearance has worsened. A low score means a better outome. Subjects were categorized to either GAIS improved or GAIS no change.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topical Combination Therapy', 'description': 'Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face\n\nTopical combination therapy'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'No topical therapies for 24 hours post-radio-frequency treatment of the face'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Topical Combination Therapy', 'description': 'Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face\n\nTopical combination therapy'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'No topical therapies for 24 hours post-radio-frequency treatment of the face'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The protocol was amended to include subjects \\>/= 75 years of age.', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tolerability of Initial Treatment', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Initial treatment - Very Tolerable', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Initial Treatment - Tolerable', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Initial Treatment - Having no opinion', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Initial treatment - Intolerable', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Initial treatment - Very intolerable', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The primary endpoint of the study is the tolerability of the combination treatment vs standard of care treatment. This baseline measure of tolerability to the first treatment is the measure from which succeeding treatments were compared to .', 'unitOfMeasure': 'Participants', 'populationDescription': 'Not all subjects had the initial treatment tolerability reported. Twenty-three subjects in each of the treatment groups reported the initial tolerability.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-18', 'size': 1674236, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-14T15:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2016-08-31', 'resultsFirstSubmitDate': '2018-04-06', 'studyFirstSubmitQcDate': '2016-09-06', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-15', 'studyFirstPostDateStruct': {'date': '2016-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment', 'timeFrame': '24hr post treatment one', 'description': 'Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.'}, {'measure': 'Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment', 'timeFrame': '72 hrs post treatment one', 'description': 'Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.'}, {'measure': 'Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment', 'timeFrame': '24hr post treatment two', 'description': 'Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.'}, {'measure': 'Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment', 'timeFrame': '72hr post treatment two', 'description': 'Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'immediately following radio-frequency treatment', 'description': "10 cm Subject discomfort scale where 10 cm indicates 'Pain as bad as it can be' and 0 cm indicates there is no pain at all associated with the application of the treatment. Zero pain means a better outcome. Subjects were categorized as to having no pain (0 - 0.4cm), mild pain (0.5 - 4.4cm), moderate pain (4.5 - 7.4cm) and severe pain (7.5 - 10cm)."}, {'measure': 'Fitzpatrick Wrinkle and Elastosis Scale', 'timeFrame': 'change in appearance of wrinkles from baseline and at end of study, average of 24 days', 'description': 'Investigator assessment of improvement in wrinkles and elastosis where Class I indicates fine wrinkles, Class II indicates fine to moderate depth wrinkles with a moderate number of lines and Class III indicates fine to deep wrinkles, numerous lines with or without redundant skin folds with a score of 1 - 3 (Mild) indicates fine texture changes with subtly accentuated skin lines, a score of 4 - 6 (Moderate) indicates distinct papular elastosis (\\[indvidual papules with yellow translucency under direct lighting\\] and dyschromia and a score of 7 - 9 (Severe) indicates multipapular and confluent elastosis \\[thickened yellow and pallid\\] approaching or consistent with cutis rhomboidalis. A lower class and a lower score means a better outcome. Subjects were divided into 3 categories - No change in FWES score, change in FWES score by one and non-evaluable.'}, {'measure': 'Global Aesthetic Improvement Scale', 'timeFrame': 'change in skin appearance between baseline and at end of study, average of 24 days', 'description': 'Investigator assessment of aesthetic improvement where 1 shows exceptional improvement, 2 shows very improved, 3 shows improvement, 4 shows unchanged and 5 indicates that the subject appearance has worsened. A low score means a better outome. Subjects were categorized to either GAIS improved or GAIS no change.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['resurfacing', 'ablation'], 'conditions': ['Skin Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor (SCR Complex) and cytokines and a botanical lipid-based occlusive (Bio Cel) immediately following fractional radiofrequency treatment using the Venus Viva versus standard of care.', 'detailedDescription': "Randomized, open-label, multi-centre study to evaluate the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor and cytokines (SCR Complex™) and a botanical lipid based occlusive (Bio Cel™) following facial fractional RF treatments using the Venus Viva™ SR system. Each subject will receive 2 treatments separated by a 3-week interval. Subjects will complete a VAS and Tolerability Scale immediately following each treatment. Telephone follow-up calls by the site will ask the subject to respond to the Self-Report Adverse Event Questionnaire 24 and 72 hours after the first treatment and 24 hours after the second treatment. Subjects will complete a Home Tolerability Scale 24 and 72 hours after the first treatment and 24 hours after the second treatment. Subjects will return for the final FU visit and be asked to respond to the Self-Report Adverse Event Questionnaire and complete the Home Tolerability Scale for 72 hours. The investigator will also evaluate the subject's improvement using the GAIS at this visit."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing a dermatological procedure requiring ablation and resurfacing of the facial skin utilizing the Venus Viva™ SR system.\n* Women of child-bearing age are required to be using a reliable method of birth control prior to enrollment and throughout their participation in the study.\n* Able to tolerate the treatment as determined by a test spot application(s).\n\nExclusion Criteria:\n\n* Superficial metal or other implants in the treatment area\n* Tattoos, permanent makeup, scars or piercings in the treatment area.\n* Any active condition in the treatment area, such as sores, psoriasis, eczema and rash.\n* Any surgical procedure in the treatment area within the last three months or before complete healing.\n* Receiving therapies or medication that may interfere with the study treatment.'}, 'identificationModule': {'nctId': 'NCT02896569', 'briefTitle': 'Tolerability of Using a Post-Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Venus Concept'}, 'officialTitle': 'Clinical Evaluation of the Tolerability of Using a Post Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation Using the Venus Viva', 'orgStudyIdInfo': {'id': 'CS0116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical combination therapy', 'description': 'Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face', 'interventionNames': ['Other: Topical combination therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Standard of care', 'description': 'No topical therapies for 24 hours post-radio-frequency treatment of the face'}], 'interventions': [{'name': 'Topical combination therapy', 'type': 'OTHER', 'otherNames': ['SCR Complex', 'Bio Cel'], 'armGroupLabels': ['Topical combination therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Dr. George Taylor', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}], 'overallOfficials': [{'name': 'Joseph L Reiz, BSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Venus Concept Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Venus Concept', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}