Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-27 @ 10:05 AM
Study NCT ID:
NCT04148651
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2019-10-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The CO2RE® System for Vulvar Lichen Sclerosus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007724', 'term': 'Vulvar Lichen Sclerosus'}, {'id': 'D007971', 'term': 'Leukoplakia'}, {'id': 'D053546', 'term': 'Keratoderma, Palmoplantar, Epidermolytic'}], 'ancestors': [{'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015776', 'term': 'Keratoderma, Palmoplantar, Diffuse'}, {'id': 'D007645', 'term': 'Keratoderma, Palmoplantar'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007642', 'term': 'Keratosis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'konikap@candelamedical.com', 'phone': '+1 949.599.7657', 'title': 'Medical Director', 'organization': 'Candela Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample size of subjects enrolled and analyzed due to delayed start at one clinical site and COVID-19 pandemic.'}}, 'adverseEventsModule': {'timeFrame': 'The period of time over which adverse event data were collected is from treatment visit until 12-month follow-up (16 month post last treatment).', 'description': 'The number and severity of adverse events following each treatment were evaluated at each treatment visit and at the follow-up visit up to 12 months after the last treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Subjects Treated With CO2RE® Treatment', 'description': 'All eligible subjects who underwent laser treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}, {'units': 'Clinical signs', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CO2RE® Treatment', 'description': 'All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.\n\nThe CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN).'}], 'classes': [{'title': 'Average score of clinical signs at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}, {'units': 'Clinical signs', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.85', 'spread': '0.73', 'groupId': 'OG000'}]}]}, {'title': 'Average score of clinical signs at 3-months follow-up visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}, {'units': 'Clinical signs', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'Average score of clinical signs at 6-months follow-up visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}, {'units': 'Clinical signs', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.76', 'groupId': 'OG000'}]}]}, {'title': 'Average score of clinical signs at 12-months follow-up visits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Clinical signs', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Baseline, 3, 6 and 12 months after the final treatment', 'description': 'Each clinical sign of VLS (loss of elasticity, sclerosis, lichenification, whitening, parchment-like skin, fissures, extent of the disease, erosions, ulcerations, hyperkeratosis, excoriation, telangiectasia) was assessed separately by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and follow-ups. For those clinical signs present at baseline (baseline score \\>0 on severity scale), an average severity grade was calculated at each endpoint to evaluate overall treatment outcome, as follows:\n\nAverage severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of clinical signs present at baseline for each subject / Number of grades\n\nA lower average score means better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Clinical signs', 'denomUnitsSelected': 'Clinical signs', 'populationDescription': 'At Baseline, 12 subjects had 96 clinical signs present (score \\>0). One subject missed the 12-month follow-up, one subject missed the 3- and 12-month follow-ups and one subject missed the 6-month follow-up. Hence, at 3- and 6-month follow-up visits 11 subjects were assessed (with 89 clinical signs averaged for each visit) and at the 12-month follow-up visit 10 subjects were assessed (with 79 clinical signs averaged).'}, {'type': 'PRIMARY', 'title': 'Average Scores for VLS Architectural Changes Present At Baseline and at 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}, {'units': 'Architectural Changes', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CO2RE® Treatment', 'description': 'All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.\n\nThe CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN).'}], 'classes': [{'title': 'Average score of architectural changes at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}, {'units': 'Architectural Changes', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.18', 'spread': '0.72', 'groupId': 'OG000'}]}]}, {'title': 'Average score of architectural changes at 3-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}, {'units': 'Architectural Changes', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.10', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'Average score of architectural changes at 6-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}, {'units': 'Architectural Changes', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.04', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Average score of architectural changes at 12-month follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}, {'units': 'Architectural Changes', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 3 , 6 and 12 months after the final treatment', 'description': 'Each architectural change of VLS (labial fusion, clitoral hood fusion, narrowing of the introitus, anterior changes, perianal involvement, formation of posterior commissure bands) was assessed separately by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and follow-ups. For those architectural changes present at baseline (baseline score \\>0 on severity scale), an average severity grade was calculated at each endpoint to evaluate overall treatment outcome, as follows:\n\nAverage severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of architectural changes present at baseline for each subject / Number of grades\n\nA lower average score means better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Architectural Changes', 'denomUnitsSelected': 'Architectural Changes', 'populationDescription': 'At Baseline, 12 patients had 55 architectural changes present (score \\>0). One subject missed the 12-month follow-up, one subject missed the 3- and 12-month follow-ups and one subject missed the 6-month follow-up. Hence, at the 3- and 6-month follow-ups, 11 subjects were assessed (with 51 architectural changes averaged for each visit) and at the 12-month follow-up 10 subjects were assessed (with 49 architectural changes averaged).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Sexual Function on the Female Sexual Function Index (FSFI) at 3 Months and 6 Months After the Final Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CO2RE® Treatment', 'description': 'All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.\n\nThe CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN).'}], 'classes': [{'title': 'Mean Change in FSFI At the 3-Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.06', 'spread': '2.25', 'groupId': 'OG000'}]}]}, {'title': 'Mean Change in FSFI At the 6-Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.53', 'spread': '2.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months and 6 months after the final treatment', 'description': 'Female Sexual Function Index (FSFI) is a validated, self-reported 19-item questionnaire that assesses domains of sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain. The aggregated FSFI score is a sum of weighted answers for each of the 19 items in the questionnaire, with a maximum total score possible of 36.0 (high level of sexual functional) and minimum score of 2.0 (low level of sexual functional). Change = (Follow-up score - Baseline score). Mean change was calculated for all scores at the 3- and 6-month follow-ups.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'At Baseline, 12 patients completed FSFI questionnaires. At the 3-month visit, 11 subjects completed the FSFI (one subject missed the visit). At the 6-month follow-up, 12 subjects completed the FSFI (one subject missed her visit but provided her self-assessments remotely).'}, {'type': 'SECONDARY', 'title': 'Subject Satisfaction At the 12-Month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Treated With CO2RE® Treatment', 'description': 'All eligible subjects who underwent laser treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months after the final treatment', 'description': 'Evaluate Subject satisfaction at the 12 months post-last treatment visit, using a satisfaction scale \\[(-2) Very dissatisfied, (-1) Dissatisfied, (0) Uncertain, (1) Satisfied, (2) Very satisfied\\]. The analysis quantify the percentage of Subject satisfaction (score 1 or 2) at the 12-month follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Two subjects missed the 12-month follow-up. Therefore, subject assessments were reported for 10 subjects at the 12-month follow-up.'}, {'type': 'SECONDARY', 'title': 'Treatment Associated Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}, {'units': 'Number of Treatments', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CO2RE® Treatment', 'description': 'All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.\n\nThe CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '2.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the 1st, 2nd, 3rd, 4th and 5th monthly treatments post baseline', 'description': 'Subjects underwent 3-5 monthly treatments and reported discomfort associated with treatment on a 10-cm visual analogue scale (VAS) of 0 = no pain to 10 = worst possible pain, immediately after each treatment. The outcome presented here is the mean grade of discomfort/pain associated with all treatments. Lower value presents lower treatment-associated discomfort. Since patients received 3-5 monthly treatments these values were collected at each treatment over a period of 2 to 4 months for each patient.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of Treatments', 'denomUnitsSelected': 'Number of Treatments', 'populationDescription': 'A total of 57 sessions were conducted (10 subjects had 5 treatments,1 subject had 4 treatments and 1 subject had 3 treatments)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CO2RE® Treatment', 'description': 'All eligible subjects underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained protocol regimen.\n\nThe CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '2 subjects did not complete the final follow-up due to COVID-19 pandemic', 'groupId': 'FG000', 'numUnits': '10', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': 'Treated areas', 'preAssignmentDetails': 'Although 14 subjects enrolled, 1 subject was withdrawn from the study due to a protocol violation and 1 subject was found to be not eligible prior to her first treatment. Therefore, 12 subjects are included in this analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CO2RE® Treatment', 'description': 'All eligible subjects that underwent up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser and maintained the protocol regimen.\n\nThe CO2RE® System: The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for treatment of leukoplakia (vulvar dystrophies).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.6', 'spread': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'FSFI', 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '10.1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The validated Female Sexual Function Index (FSFI) was used to compare sexual function to baseline. FSFI score, a 19-item validated questionnaire assesses domains of sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain, in addition to providing an overall score regarding sexual function. The aggregated FSFI score is a sum of weighted answers for each of the 19 items in the questionnaire with a maximum score 36.0 (high level of sexual functional) and minimum score of 2.0 (low level of sexual functional).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Although 14 subjects enrolled, 1 subject was withdrawn from the study due to a protocol violation and 1 subject was found to be not eligible prior to her first treatment. Both are not included in the Results analysis.'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2019-02-19', 'size': 653456, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-12-31T15:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-23', 'studyFirstSubmitDate': '2019-10-29', 'resultsFirstSubmitDate': '2020-12-31', 'studyFirstSubmitQcDate': '2019-10-30', 'lastUpdatePostDateStruct': {'date': '2022-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-31', 'studyFirstPostDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Scores for VLS Clinical Signs Present At Baseline, 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators', 'timeFrame': 'At Baseline, 3, 6 and 12 months after the final treatment', 'description': 'Each clinical sign of VLS (loss of elasticity, sclerosis, lichenification, whitening, parchment-like skin, fissures, extent of the disease, erosions, ulcerations, hyperkeratosis, excoriation, telangiectasia) was assessed separately by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and follow-ups. For those clinical signs present at baseline (baseline score \\>0 on severity scale), an average severity grade was calculated at each endpoint to evaluate overall treatment outcome, as follows:\n\nAverage severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of clinical signs present at baseline for each subject / Number of grades\n\nA lower average score means better outcome.'}, {'measure': 'Average Scores for VLS Architectural Changes Present At Baseline and at 3, 6 and 12 Months After the Last Treatment as Assessed by the Investigators', 'timeFrame': 'Baseline, 3 , 6 and 12 months after the final treatment', 'description': 'Each architectural change of VLS (labial fusion, clitoral hood fusion, narrowing of the introitus, anterior changes, perianal involvement, formation of posterior commissure bands) was assessed separately by the investigator, using a 4-point scale (0=not present, 1=mild, 2=moderate or 3=severe) for each subject at baseline and follow-ups. For those architectural changes present at baseline (baseline score \\>0 on severity scale), an average severity grade was calculated at each endpoint to evaluate overall treatment outcome, as follows:\n\nAverage severity grade = Sum of all severity grades (0, 1, 2, or 3) for each individual parameter of architectural changes present at baseline for each subject / Number of grades\n\nA lower average score means better outcome.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Sexual Function on the Female Sexual Function Index (FSFI) at 3 Months and 6 Months After the Final Treatment', 'timeFrame': 'Baseline and 3 months and 6 months after the final treatment', 'description': 'Female Sexual Function Index (FSFI) is a validated, self-reported 19-item questionnaire that assesses domains of sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain. The aggregated FSFI score is a sum of weighted answers for each of the 19 items in the questionnaire, with a maximum total score possible of 36.0 (high level of sexual functional) and minimum score of 2.0 (low level of sexual functional). Change = (Follow-up score - Baseline score). Mean change was calculated for all scores at the 3- and 6-month follow-ups.'}, {'measure': 'Subject Satisfaction At the 12-Month Follow-up', 'timeFrame': '12 months after the final treatment', 'description': 'Evaluate Subject satisfaction at the 12 months post-last treatment visit, using a satisfaction scale \\[(-2) Very dissatisfied, (-1) Dissatisfied, (0) Uncertain, (1) Satisfied, (2) Very satisfied\\]. The analysis quantify the percentage of Subject satisfaction (score 1 or 2) at the 12-month follow-up.'}, {'measure': 'Treatment Associated Pain Score', 'timeFrame': 'Immediately after the 1st, 2nd, 3rd, 4th and 5th monthly treatments post baseline', 'description': 'Subjects underwent 3-5 monthly treatments and reported discomfort associated with treatment on a 10-cm visual analogue scale (VAS) of 0 = no pain to 10 = worst possible pain, immediately after each treatment. The outcome presented here is the mean grade of discomfort/pain associated with all treatments. Lower value presents lower treatment-associated discomfort. Since patients received 3-5 monthly treatments these values were collected at each treatment over a period of 2 to 4 months for each patient.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['vulvar dystrophy', 'vulvar atrophy', 'persistent itching', 'leukoplakia', 'hyperkeratosis', 'sexual function'], 'conditions': ['Vulvar Lichen Sclerosus']}, 'referencesModule': {'references': [{'pmid': '29095746', 'type': 'BACKGROUND', 'citation': 'Sheinis M, Selk A. Development of the Adult Vulvar Lichen Sclerosus Severity Scale-A Delphi Consensus Exercise for Item Generation. J Low Genit Tract Dis. 2018 Jan;22(1):66-73. doi: 10.1097/LGT.0000000000000361.'}, {'pmid': '10782451', 'type': 'BACKGROUND', 'citation': "Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597."}, {'pmid': '22594865', 'type': 'BACKGROUND', 'citation': 'Thorstensen KA, Birenbaum DL. Recognition and management of vulvar dermatologic conditions: lichen sclerosus, lichen planus, and lichen simplex chronicus. J Midwifery Womens Health. 2012 May-Jun;57(3):260-75. doi: 10.1111/j.1542-2011.2012.00175.x.'}, {'pmid': '25608269', 'type': 'BACKGROUND', 'citation': 'Salvatore S, Leone Roberti Maggiore U, Athanasiou S, Origoni M, Candiani M, Calligaro A, Zerbinati N. Histological study on the effects of microablative fractional CO2 laser on atrophic vaginal tissue: an ex vivo study. Menopause. 2015 Aug;22(8):845-9. doi: 10.1097/GME.0000000000000401.'}, {'pmid': '34541702', 'type': 'RESULT', 'citation': 'Stewart K, Javaid S, Schallen KP, Bartlett S, Carlson NA. Fractional CO2 laser treatment as adjunctive therapy to topical steroids for managing vulvar lichen sclerosus. Lasers Surg Med. 2022 Jan;54(1):138-151. doi: 10.1002/lsm.23476. Epub 2021 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'Subjects with vulvar lichen sclerosus (VLS) will undergo fractional carbon dioxide (CO2) laser treatment to the vulvar area. Subjects will be evaluated for changes in clinical signs and architectural changes associated with VLS at designated follow-ups to 1-year post treatment series.', 'detailedDescription': 'This study is a prospective, non-randomized, single-group assignment, interventional clinical trial. Female subjects with vulvar lichen sclerosus (VLS) supported by histologic findings on biopsy and/or clinical signs on physical examination and recalcitrant to mid- to high-potency steroid therapy, will undergo up to 5 monthly treatments to the vulva with a fractional CO2 laser.\n\nInvestigators will assess clinical signs and architectural changes associated with VLS. Baseline measurements will be compared to follow-up at 6 weeks, 3 months, 6 months and 12 months after the final treatment.\n\nSubjects will self report sexual function using a validated FSFI Questionnaire at baseline and at the 3- and 6-month follow-ups.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able to read, understand and sign informed consent for study participation;\n2. Female subjects with age 18-80 years;\n3. Biopsy demonstrates biopsy-proven lichen sclerosus and/or there are characteristic changes for vulvar lichen sclerosus on physical examination;\n4. Treatment of LS has been recalcitrant to mid to high-potent topical corticosteroid treatment or subject refuses topical corticosteroid treatment. Recalcitrance to therapy is defined as no response to topical corticosteroids of an adequate potency (i.e. clobetasol propionate 0.05% ointment or other steroids) and a sufficient duration (12 weeks of use) or lack of symptomatic control of the disease with a maintenance therapy;\n5. Topical corticosteroid treatment, if any, will be continued during the study period;\n6. Exogenous hormone treatment, if any, will be continued during the study period (type and dose must stay consistent throughout the study);\n7. One or more of the following symptoms: itch; pain unrelated to intercourse; pain, skin tearing or bleeding with intercourse; changes/decrease in sexual function;\n8. No breaks, tears or lesions, malodorous discharge or strawberry cervix present on gynecological exam.\n\nExclusion Criteria:\n\n1. Presence of clinically atypical appearing nevi in the area to be treated;\n2. Unexplained vaginal bleeding;\n3. Active infection, specifically: urinary tract infection, vulvar or vaginal infection (candidiasis, genital herpes/herpes simplex virus, bacterial vaginosis, trichomonas);\n4. History of vulvar or any gynecological malignancy, as well as history of pelvic radiation therapy or stem cell transplant;\n5. Pelvic organ prolapse \\> stage 2;\n6. Pregnancy or planning pregnancy during the study;\n7. Systemic treatment with immuno-modulatory drugs.\n8. Use of vaginal dilators during study.'}, 'identificationModule': {'nctId': 'NCT04148651', 'briefTitle': 'The CO2RE® System for Vulvar Lichen Sclerosus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Candela Corporation'}, 'officialTitle': 'Clinical Study of the CO2RE® Laser Device for Treatment of Vulvar Lichen Sclerosus', 'orgStudyIdInfo': {'id': 'DHF25211'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CO2RE® Treatment', 'description': 'All eligible subjects will undergo up to 5 treatments at 4±1-week intervals to the vulva with a fractional CO2 laser.', 'interventionNames': ['Device: The CO2RE® System']}], 'interventions': [{'name': 'The CO2RE® System', 'type': 'DEVICE', 'description': 'The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of leukoplakia (vulvar dystrophies).', 'armGroupLabels': ['CO2RE® Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Total Dermatology Care Center', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Center for Modern Aesthetic Medicine', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '45249', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'HERmd (formerly Somi Javaid M.D. & Associates)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '05403', 'city': 'South Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Lumina Med Spa', 'geoPoint': {'lat': 44.46699, 'lon': -73.17096}}], 'overallOfficials': [{'name': 'Konika P Schallen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Candela Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Candela Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}