Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT04345094
Status:
COMPLETED
Last Update Posted:
2020-07-10
First Post:
2020-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Hexyresorcinol vs Hydroquinone for Photoaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C031927', 'term': 'hydroquinone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2020-04-10', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Subjective Tolerability Assessment', 'timeFrame': 'Assessed at Week 4, 8, and 12', 'description': 'Assessed through subjective questionnaire'}], 'primaryOutcomes': [{'measure': 'To assess the use of topical hexylresorcinol versus hydroquinone skin regimen on the objective appearance of skin photoaging - specifically appearance of pigment.', 'timeFrame': '12 weeks', 'description': 'Assessed Through Skin Colorimeter (Validated Measurement Tool) - by melanin measurement on cheeks, hands, and face.'}, {'measure': 'To assess the use of topical hexylresorcinol versus hydroquinone skin regimen on the clinical grading of appearance of skin photoaging - specifically appearance of pigment.', 'timeFrame': '12 weeks', 'description': 'Pigment was assessed through clinical grading of 0 (none) to 3 (severe) scale by board-certified dermatologist of each side of the face.'}], 'secondaryOutcomes': [{'measure': 'Observe and assess changes in the appearance of skin redness', 'timeFrame': '12 weeks', 'description': 'Assessed using skin colorimeter (validated measurement tool) - by erythema measurement'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Photoaging']}, 'referencesModule': {'references': [{'pmid': '36502500', 'type': 'DERIVED', 'citation': 'Wu H, Gabriel TA, Burney WA, Chambers CJ, Pan A, Sivamani RK. Prospective, randomized, double-blind clinical study of split-body comparison of topical hydroquinone and hexylresorcinol for skin pigment appearance. Arch Dermatol Res. 2023 Jul;315(5):1207-1214. doi: 10.1007/s00403-022-02514-0. Epub 2022 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'Photoaging is a common concern within the cosmeceutical industry with many products that are available. One frequently used product is hydroquinone that is used to even skin tone. However, hydroquinone has several shortcomings. The ingredient is controversial for its potential safety issues and it has been banned in Europe. An alternative ingredient that has emerged for its potential use is hexyresorcinol for evening skin tone. Additionally, hexylresorcinol may have other photoaging benefits such as the reduction in the appearance of fine lines.\n\nTherefore, the aim of this study is to assess how hexyresorcinol may compare to the use of hydroquinone in the setting of photoaging.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Females aged 35-65 (limiting to females so that there is not heterogeneity with the influence of hormones. Also, females are a much larger user base of skin care products)\n* Individuals who have not participated in any other clinical studies using the same test sites (face) and hand in the past 14 days\n* Individuals with Fitzpatrick skin type I-IV\n* No known medical conditions that, in the investigator's opinion, may interfere with study participation.\n\nExclusion Criteria:\n\n* • Individuals who have been on any medication that has caused a change in skin pigmentation based on the opinion of the investigator\n\n * Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator\n * Female volunteers who are pregnant or are actively breastfeeding or planning a pregnancy within two months. (There is no concern for risk to fetus but pregnancy can alter skin pigmentation)\n * Female volunteers who have started a new hormonal birth control agent or switched to a hormonal birth control agent within the past 60 days\n * Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure\n * Individuals who are currently using or during the past 30 days have used hydroquinone, or a retinoid such as Retin A, or other Rx/OTC Retinyl A.\n * Individuals who have used salicyclic acid, beta hydroxy acid, vitamins A, C, E in the 14 days prior to first visit.\n * Individuals with a known history of hypersensitivity to any ingredients to the cosmetic agent that is being assessed\n * Individuals who are pregnant, breast feeding or planning a pregnancy.\n * Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator"}, 'identificationModule': {'nctId': 'NCT04345094', 'briefTitle': 'Evaluation of Hexyresorcinol vs Hydroquinone for Photoaging', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sytheon Ltd.'}, 'officialTitle': 'Randomized, Double-Blind Evaluation of Hexyresorcinol vs Hydroquinone for Photoaging', 'orgStudyIdInfo': {'id': 'HHSOL-1495-125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Comparator', 'description': 'Emulsion containing 1% Hexylresourcinol', 'interventionNames': ['Other: Hexylresourcinol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Emulsion containing 2% Hydroquinone', 'interventionNames': ['Other: Hydroquinone']}], 'interventions': [{'name': 'Hexylresourcinol', 'type': 'OTHER', 'description': 'Emulsion containing hexylresorcinol as an active', 'armGroupLabels': ['Comparator']}, {'name': 'Hydroquinone', 'type': 'OTHER', 'description': 'Emulsions containing hydroquinone as an active', 'armGroupLabels': ['Intervention']}]}, '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': 'Pacific Skin Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will be published in a scientific journal with raw data made available to researchers upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sytheon Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President', 'investigatorFullName': 'Ratan K. Chaudhuri', 'investigatorAffiliation': 'Sytheon Ltd.'}}}}