Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT06178367
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2023-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Topical Hyaluronic Acid of Different Molecular Weights in Xerotic Skin Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All moisturizers used in this clinical trial were made in the same preparation and packaging'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a split study, one participant receive three interventions in three area in the leg. The distribution of treatment groups is carried out randomly using the block randomization method.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-26', 'studyFirstSubmitDate': '2023-12-10', 'studyFirstSubmitQcDate': '2023-12-10', 'lastUpdatePostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin capacitance', 'timeFrame': '2 weeks and 4 weeks', 'description': 'Skin capacitance is measured by Corneometer CM825'}, {'measure': 'Transepidermal water loss', 'timeFrame': '2 weeks and 4 weeks', 'description': 'Transepidermal water loss is measured by Tewameter TM300'}, {'measure': 'Specified symptom sum score/scale, roughness, redness, crack (SRRC)', 'timeFrame': '2 weeks and 4 weeks', 'description': 'Evaluation of squama/scale, roughness, redness, and crack of the skin, with a value range of 0-16. Higher values mean worse outcome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Xerosis Cutis']}, 'referencesModule': {'references': [{'pmid': '22052267', 'type': 'RESULT', 'citation': 'Pavicic T, Gauglitz GG, Lersch P, Schwach-Abdellaoui K, Malle B, Korting HC, Farwick M. Efficacy of cream-based novel formulations of hyaluronic acid of different molecular weights in anti-wrinkle treatment. J Drugs Dermatol. 2011 Sep;10(9):990-1000.'}, {'pmid': '36074117', 'type': 'RESULT', 'citation': 'Ha NG, Lee SH, Lee EH, Chang M, Yoo J, Lee WJ. Safety and efficacy of a new hydrogel based on hyaluronic acid as cosmeceutical for xerosis. J Cosmet Dermatol. 2022 Dec;21(12):6840-6849. doi: 10.1111/jocd.15368. Epub 2022 Sep 20.'}, {'pmid': '38829483', 'type': 'DERIVED', 'citation': 'Muhammad P, Novianto E, Setyorini M, Legiawati L, Yusharyahya SN, Menaldi SL, Budianti WK. Effectiveness of topical hyaluronic acid of different molecular weights in xerosis cutis treatment in elderly: a double-blind, randomized controlled trial. Arch Dermatol Res. 2024 Jun 3;316(6):329. doi: 10.1007/s00403-024-03003-2.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare 0,1% topical low molecular weight (7 kDa) hyaluronic acid with 0,1% high molecular weight (1.800 kDa) hyaluronic acid as therapy of xerotic skin in elderly', 'detailedDescription': 'This clinical trial is conducted to compare the effectiveness and safety between moisturizers containing 0,1% low molecular weight hyaluronic acid, 0,1% high molecular weight hyaluronic acid, and its vehicle on skin hydration of elderly with xerotic skin. It is designed to answer following questions:\n\n1. Is the skin capacitance in the elderly after using moisturizers containing low molecular weight hyaluronic acid higher than high molecular weight hyaluronate acid and vehicle?\n2. Is the transepidermal water loss in the elderly after using moisturizers containing high molecular weight hyaluronic acid lower than low molecular weight hyaluronate acid and vehicle?\n3. Is the dry skin score (SRRC) in the elderly after using moisturizers containing low molecular weight hyaluronic acid lower than high molecular weight hyaluronate acid and vehicle?\n4. Is there any difference in occurence of side effect in elderly between the use of moisturizers containing low molecular weight hyaluronic acid, high molecular weight hyaluronic acid, and vehicle?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male diagnosed with xerotic skin\n* 60-80 years old\n* Willing to participate in clinical trial and sign informed consent\n\nExclusion Criteria:\n\n* History of hypersensitivity to moisturizer\n* Dermatitis or any dermatosis on intervention area in the leg\n* Score of erythema and crack more than 2, based on SRRC scoring'}, 'identificationModule': {'nctId': 'NCT06178367', 'briefTitle': 'Effectiveness and Safety of Topical Hyaluronic Acid of Different Molecular Weights in Xerotic Skin Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Effectiveness and Safety Comparison Between Moisturizers Containing Low Molecular Weight Hyaluronic Acid, High Molecular Weight Hyaluronic Acid, and Vehicle on Skin Hydration in the Elderly With Xerotic Skin', 'orgStudyIdInfo': {'id': '23061046'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical 0,1% low molecular weight (7 kDa) hyaluronic acid', 'description': 'Participants receive moisturizer containing 0,1% low molecular weight (7 kDa) hyaluronic acid on 7 cm x 7 cm area on the right or left leg based on the randomization, twice a day for 1 month', 'interventionNames': ['Drug: Low molecular weight hyaluronic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid', 'description': 'Participants receive moisturizer containing 0,1% high molecular weight (1.800 kDa) hyaluronic acid on 7 cm x 7 cm area on the right or left leg based on the randomization, twice a day for 1 month', 'interventionNames': ['Drug: High molecular weight hyaluronic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Participants receive vehicle on 7 cm x 7 cm area on the right or left leg based on the randomization, twice a day for 1 month.', 'interventionNames': ['Drug: Vehicle']}], 'interventions': [{'name': 'Low molecular weight hyaluronic acid', 'type': 'DRUG', 'otherNames': ['LMWHA'], 'description': 'Topical 0,1% low molecular weight (7 kDa) hyaluronic acid in vehicle', 'armGroupLabels': ['Topical 0,1% low molecular weight (7 kDa) hyaluronic acid']}, {'name': 'High molecular weight hyaluronic acid', 'type': 'DRUG', 'otherNames': ['HMWHA'], 'description': 'Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid in vehicle', 'armGroupLabels': ['Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid']}, {'name': 'Vehicle', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Vehicle ingredients including aqua, paraffinum liquidum, glycerin, petrolatum, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, arachidyl alcohol, squalane, behenyl alcohol, phenoxyethanol, arachidyl glucoside, allantoin, chlorphenesin, and disodium EDTA', 'armGroupLabels': ['Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12420', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Panti Sosial Tresna Werdha Budi Mulia 3', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Parikesit Muhammad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, University of Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dermatology and Venereology Resident', 'investigatorFullName': 'Parikesit Muhammad', 'investigatorAffiliation': 'Indonesia University'}}}}