Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT01027793
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2009-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057896', 'term': 'Striae Distensae'}], 'ancestors': [{'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cientifico@cbed.org.br', 'phone': '+55 51 30262633', 'title': 'Dr. Doris Hexsel', 'organization': 'Brazilian Center for Studies in Dermatology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tretinoin', 'description': 'Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.\n\nTretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Superficial Dermabrasion', 'description': 'Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.\n\nSuperficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pruritus', 'notes': 'Itching on the treated area.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erythema', 'notes': 'Erythema on the treated area.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Scaling', 'notes': 'Scaling on the treated area', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stinging', 'notes': 'Stinging on the treated area', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Width of Stretch Marks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tretinoin', 'description': 'Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.\n\nTretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.'}, {'id': 'OG001', 'title': 'Superficial Dermabrasion', 'description': 'Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.\n\nSuperficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.199', 'spread': '0.129', 'groupId': 'OG000'}, {'value': '0.146', 'spread': '0.052', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0.088', 'spread': '0.073', 'groupId': 'OG000'}, {'value': '0.077', 'spread': '0.040', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 16 weeks', 'description': 'Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol.'}, {'type': 'PRIMARY', 'title': 'Length of Stretch Marks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tretinoin', 'description': 'Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.\n\nTretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.'}, {'id': 'OG001', 'title': 'Superficial Dermabrasion', 'description': 'Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.\n\nSuperficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.371', 'spread': '0.631', 'groupId': 'OG000'}, {'value': '1.518', 'spread': '0.386', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0.894', 'spread': '0.457', 'groupId': 'OG000'}, {'value': '1.111', 'spread': '0.673', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 16 weeks', 'description': 'Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol.'}, {'type': 'SECONDARY', 'title': 'Global Aesthetic Improvement Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tretinoin', 'description': 'Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.\n\nTretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.'}, {'id': 'OG001', 'title': 'Superficial Dermabrasion', 'description': 'Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.\n\nSuperficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks', 'description': '1. Very much improved: Optimal cosmetic result for the implant in this patient\n2. Much improved: Marked improvement in appearance from the initial condition but not completely optimal for this patient; touch-up would slightly improve the result 3 - Improved: Obvious improvement in appearance from the initial condition, but touch-up or retreatment is indicated 4 - No change: Appearance essentially the same as the original condition 5 - Worse: Appearance worse than the original condition', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol.'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tretinoin', 'description': 'Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.\n\nTretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.'}, {'id': 'OG001', 'title': 'Superficial Dermabrasion', 'description': 'Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.\n\nSuperficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center'}], 'classes': [{'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Satisfied', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Neither satisfied nor unsatisfied', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks', 'description': 'Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tretinoin', 'description': 'Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.\n\nTretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.'}, {'id': 'FG001', 'title': 'Superficial Dermabrasion', 'description': 'Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.\n\nSuperficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tretinoin', 'description': 'Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.\n\nTretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.'}, {'id': 'BG001', 'title': 'Superficial Dermabrasion', 'description': 'Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.\n\nSuperficial Dermabrasion: Group 2 will receive 16 sessions of dermabrasion that would be held in the research center'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'spread': '4.3', 'groupId': 'BG000'}, {'value': '17.0', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '16.9', 'spread': '3.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fitzpatrick skin phototype', 'classes': [{'categories': [{'title': 'Fitzpatrick skin phototype I', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Fitzpatrick skin phototype II', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Fitzpatrick skin phototype III', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Fitzpatrick skin phototype IV', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Fitzpatrick skin phototype V', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Fitzpatrick skin phototype VI', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Phototype I - Pale white skin, blue/green eyes, blond/red hair; Always burns, does not tan Phototype II - Fair skin, blue eyes; Burns easily, tans poorly Phototype III - Darker white skin; Tans after initial burn Phototype IV - Light brown skin; Burns minimally, tans easily Phototype V - Brown skin; Rarely burns, tans darkly easily Phototype VI - Dark brown or black skin; Never burns, always tans darkly', 'unitOfMeasure': 'Participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '23.7', 'spread': '4.4', 'groupId': 'BG000'}, {'value': '24.8', 'spread': '3.3', 'groupId': 'BG001'}, {'value': '24.3', 'spread': '3.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Per protocol assessment'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-04', 'studyFirstSubmitDate': '2009-12-08', 'resultsFirstSubmitDate': '2020-12-07', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-04', 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Width of Stretch Marks', 'timeFrame': 'Baseline and 16 weeks', 'description': 'Striae width was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)'}, {'measure': 'Length of Stretch Marks', 'timeFrame': 'Baseline and 16 weeks', 'description': 'Striae length was measured with Mirror Medical Imaging Software (Canfield Scientific, Inc., Parsippany, NJ)'}], 'secondaryOutcomes': [{'measure': 'Global Aesthetic Improvement Scale', 'timeFrame': '16 weeks', 'description': '1. Very much improved: Optimal cosmetic result for the implant in this patient\n2. Much improved: Marked improvement in appearance from the initial condition but not completely optimal for this patient; touch-up would slightly improve the result 3 - Improved: Obvious improvement in appearance from the initial condition, but touch-up or retreatment is indicated 4 - No change: Appearance essentially the same as the original condition 5 - Worse: Appearance worse than the original condition'}, {'measure': 'Patient Satisfaction', 'timeFrame': '16 weeks', 'description': 'Patient satisfaction measured with Lickert scale (Very satisfied, Satisfied, Neither satisfied nor unsatisfied, unsatisfied, very unsatisfied)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stretch marks', 'Striae', 'Tretinoin', 'Superficial dermabrasion'], 'conditions': ['Stretch Marks', 'Striae', 'Treatment']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate head-to-head the effectiveness of tretinoin 0.5% and superficial dermabrasion in subjects that have recent stretch marks.', 'detailedDescription': 'Healthy female subjects, from 11 t0 25 years old, that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks.\n\nThirty subjects will be randomly divided in two groups:\n\nGroup 1 will receive tretinoin cream that should be applied daily in areas affected by stretch marks.\n\nGroup 2 will receive 16 sessions of dermabrasion that would be held in the research center.\n\nSubjects will be evaluated by pictures, measurement of width and length of stretch marks, using Mirror System(Canfield).\n\nBiopsy to quantify alterations of epidermis and dermis of treated area, will be held pre-treatment and 2 weeks after the conclusion of treatment. For biopsy will be used a punch of 3mm.\n\nThe results will be evaluated two weeks after the conclusion of the interventions. An independent dermatologist, blinded for intervention, will analyse pictures pre and post treatment. This subjective evaluation will be performed using Global Aesthetic Improvement Scale.\n\nSafety and adverse events will be assessed each visit.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects, aged between 11 and 25 years\n* Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method for at least 3 months prior the study\n* Subjects that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks\n* Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form\n* Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol\n* Subjects who had never received treatment for striae in the studied area\n\nExclusion Criteria:\n\n* Subjects whose medical history and physical examination present clinical pathology, as marfan Syndrome, cushing, systemic autoimmune or neurological diseases\n* Pregnant or women in breastfeeding, or women planning to become pregnant\n* Previous treatment for striae in the local area of the study.\n* Subjects that are in use of tretinoin or glycolic acid in the local area of the study.\n* Presence of white striae in the local area of the study\n* History of Connective Tissue Disease\n* History of keloid development or skin healing problems\n* Subjects that are taking medications associated with striae development, as systemic corticosteroids, indinavir, hormonal replacement therapy\n* Hypersensibility to retinoic acid\n* Subjects who intend to get tan in the area of the study, through exposure of sun or tanning machines during the study\n* Subjects that have a variation in their weight of more than 2 kg in a period of four months prior the study\n* Predisposition for chronic inflammatory process\n* Subjects with chronic diseases as diabetes, cardiopathy, neoplasm, HIV and autoimmune diseases (vitiligo, lupus)'}, 'identificationModule': {'nctId': 'NCT01027793', 'briefTitle': 'Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Stretch Marks', 'organization': {'class': 'OTHER', 'fullName': 'Hexsel Dermatology Clinic'}, 'officialTitle': 'Randomized Clinical Trial Comparing Treatment of Tretinoin or Superficial Dermabrasion for Recent Stretch Marks', 'orgStudyIdInfo': {'id': '11-CBED08-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tretinoin', 'description': 'Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.', 'interventionNames': ['Drug: Tretinoin cream 0.005%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Superficial Dermabrasion', 'description': 'Group 2 will receive 16 sessions of dermabrasion that would be held in the research center.', 'interventionNames': ['Device: Superficial Dermabrasion']}], 'interventions': [{'name': 'Tretinoin cream 0.005%', 'type': 'DRUG', 'otherNames': ['(Vitanol A, Stiefel)'], 'description': 'Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.', 'armGroupLabels': ['Tretinoin']}, {'name': 'Superficial Dermabrasion', 'type': 'DEVICE', 'description': 'Group 2 will receive 16 sessions of dermabrasion that would be held in the research center', 'armGroupLabels': ['Superficial Dermabrasion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90570 040', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Brazilian Center for Studies in Dermatology', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Doris M Hexsel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Brazilian Center For Studies in Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hexsel Dermatology Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Doris Hexsel', 'investigatorAffiliation': 'Hexsel Dermatology Clinic'}}}}