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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical 0,1% low molecular weight (7 kDa) hyaluronic acid | Experimental | 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 |
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| Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid | Active Comparator | 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 |
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| Vehicle | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low molecular weight hyaluronic acid | Drug | Topical 0,1% low molecular weight (7 kDa) hyaluronic acid in vehicle |
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| Measure | Description | Time Frame |
|---|---|---|
| Skin capacitance | Skin capacitance is measured by Corneometer CM825 | 2 weeks and 4 weeks |
| Transepidermal water loss | Transepidermal water loss is measured by Tewameter TM300 | 2 weeks and 4 weeks |
| Specified symptom sum score/scale, roughness, redness, crack (SRRC) | Evaluation of squama/scale, roughness, redness, and crack of the skin, with a value range of 0-16. Higher values mean worse outcome | 2 weeks and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parikesit Muhammad, MD | Faculty of Medicine, University of Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panti Sosial Tresna Werdha Budi Mulia 3 | Jakarta | DKI Jakarta | 12420 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22052267 | Result | 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. | |
| 36074117 | Result | 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. |
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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.
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All moisturizers used in this clinical trial were made in the same preparation and packaging
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| High molecular weight hyaluronic acid | Drug | Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid in vehicle |
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| Vehicle | Drug | 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 |
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| 38829483 | Derived | 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. |