Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-05 @ 5:59 AM
Study NCT ID:
NCT05778760
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2023-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study of Topical Adapinoid Versus Topical Retinol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014801', 'term': 'Vitamin A'}], 'ancestors': [{'id': 'D012176', 'term': 'Retinoids'}, {'id': 'D002338', 'term': 'Carotenoids'}, {'id': 'D011090', 'term': 'Polyenes'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D053138', 'term': 'Cyclohexenes'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D010860', 'term': 'Pigments, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-15', 'studyFirstSubmitDate': '2023-03-10', 'studyFirstSubmitQcDate': '2023-03-10', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Facial fine lines and wrinkles', 'timeFrame': '12 weeks', 'description': 'Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)'}], 'secondaryOutcomes': [{'measure': 'Facial fine lines and wrinkles', 'timeFrame': '4 weeks', 'description': 'Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)'}, {'measure': 'Facial fine lines and wrinkles', 'timeFrame': '8 weeks', 'description': 'Change in severity of fine lines and wrinkles measured by photographic analysis (BTBP 3D Camera System)'}, {'measure': 'Skin redness', 'timeFrame': '4 weeks', 'description': 'Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)'}, {'measure': 'Skin redness', 'timeFrame': '8 weeks', 'description': 'Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)'}, {'measure': 'Skin redness', 'timeFrame': '12 weeks', 'description': 'Change in the appearance of skin redness measured by photographic analysis (BTBP 3D Camera System)'}, {'measure': 'Facial skin pigment evenness', 'timeFrame': '4 weeks', 'description': 'Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)'}, {'measure': 'Facial skin pigment evenness', 'timeFrame': '8 weeks', 'description': 'Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)'}, {'measure': 'Facial skin pigment evenness', 'timeFrame': '12 weeks', 'description': 'Change in the appearance of facial skin pigment intensity measured by photographic analysis (BTBP 3D Camera System)'}, {'measure': 'Self-perception of skin health and appearance', 'timeFrame': '4 weeks', 'description': 'Survey-based self-assessment of aspects of skin health and appearance'}, {'measure': 'Self-perception of skin health and appearance', 'timeFrame': '8 weeks', 'description': 'Survey-based self-assessment of aspects of skin health and appearance'}, {'measure': 'Self-perception of skin health and appearance', 'timeFrame': '12 weeks', 'description': 'Survey-based self-assessment of aspects of skin health and appearance'}, {'measure': 'Tolerability of product', 'timeFrame': '4 weeks', 'description': 'Questionnaire based self-assessment about the tolerability of the topical skin product'}, {'measure': 'Tolerability of product', 'timeFrame': '8 weeks', 'description': 'Questionnaire based self-assessment about the tolerability of the topical skin product'}, {'measure': 'Tolerability of product', 'timeFrame': '12 weeks', 'description': 'Questionnaire based self-assessment about the tolerability of the topical skin product'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anti-aging', 'skin care'], 'conditions': ['Wrinkle']}, 'referencesModule': {'references': [{'pmid': '39624736', 'type': 'DERIVED', 'citation': 'Nguyen N, Afzal N, Min M, Ahmad N, Afzal L, Burney W, Chambers CJ, Sivamani RK. A prospective, double-blinded, randomized head-to-head clinical trial of topical adapinoid (oleyl adapalenate) versus retinol. Skin Health Dis. 2024 Nov 4;4(6):e469. doi: 10.1002/ski2.469. eCollection 2024 Dec.'}]}, 'descriptionModule': {'briefSummary': 'This study is to analyze and compare the effects of applying two topical vitamin-A derived ingredients on facial skin health, appearance and tolerability. One of these ingredients is retinol, and the other is Adapinoid, also known as Oleyl Adapalenate, a novel anti-aging ingredient.', 'detailedDescription': 'We want to assess the effect of applying vitamin A-derived ingredients on facial skin health, appearance, and tolerability. One of these ingredients is retinol, and the other is Adapinoid, also known as Oleyl Adapalenate.\n\nIn this study, participants will be randomized to either receiving a retinol product, or an Adapinoid product and they will be assessed at three follow up visits at week 4, week 8, and week 12.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women between the ages of 35 years old and 65 years old\n\nExclusion Criteria:\n\n* Individuals who are pregnant or breastfeeding.\n* Prisoners.\n* Adults unable to consent.\n* Individuals who have changed any of their hormonal based contraception within 3 months prior to joining the study.\n* Subjects using any topical retinoid, acetyl zingerone, vitamin C, bakuchiol, hyaluronic acid or benzoyl peroxide containing topical product within 2 weeks of starting study or any subject unwilling to refrain from washout prior to enrollment.\n* Subjects with any of the following facial cosmetic treatments in the past 3 months or those who are unwilling to withhold the following facial cosmetic treatments during study including botulinum toxin, injectable fillers, microdermabrasion, intense pulsed light (IPL), peels, laser treatments, acid treatments, facial plastic surgery, or any other medical treatment administered by a physician or skin care professional which is designed to improve the appearance of facial skin.\n* Current tobacco smoker or a tobacco smoking history of greater than 10 pack-years.'}, 'identificationModule': {'nctId': 'NCT05778760', 'briefTitle': 'Prospective Study of Topical Adapinoid Versus Topical Retinol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integrative Skin Science and Research'}, 'officialTitle': 'Prospective, Double-Blinded, Randomized Head-to-Head Study of Topical Adapinoid Versus Topical Retinol', 'orgStudyIdInfo': {'id': 'ADAP_RET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Retinol', 'description': 'Product will be used once daily in the evening for 12 weeks. 1-2 pumps (size of quarter) of product will be applied on the face.', 'interventionNames': ['Other: Retinol']}, {'type': 'EXPERIMENTAL', 'label': 'Adapinoid', 'description': 'Product will be used once daily in the evening for 12 weeks. 1-2 pumps (size of quarter) of product will be applied on the face.', 'interventionNames': ['Other: Adapinoid']}], 'interventions': [{'name': 'Retinol', 'type': 'OTHER', 'description': 'Topical retinol (0.5%) applied to the face', 'armGroupLabels': ['Retinol']}, {'name': 'Adapinoid', 'type': 'OTHER', 'description': 'Topical Adapinoid (0.5%) applied to the face', 'armGroupLabels': ['Adapinoid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95815', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Integrative Skin Science and Research', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Raja Sivamani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Integrative Skin Science and Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integrative Skin Science and Research', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Actera (Sponsor)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}