Clinical trial NCT06178367: Effectiveness and Safety of Topical Hyaluronic Acid of Different Molecular Weights in Xerotic Skin Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Xerosis Cutis
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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:

1. 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?
2. 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?
3. 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?
4. 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?

Eligibility criteria: Inclusion Criteria:

* Female or male diagnosed with xerotic skin
* 60-80 years old
* Willing to participate in clinical trial and sign informed consent

Exclusion Criteria:

* History of hypersensitivity to moisturizer
* Dermatitis or any dermatosis on intervention area in the leg
* Score of erythema and crack more than 2, based on SRRC scoring

Primary outcomes:
measure: Skin capacitance
timeFrame: 2 weeks and 4 weeks
measure: Transepidermal water loss
timeFrame: 2 weeks and 4 weeks
measure: Specified symptom sum score/scale, roughness, redness, crack (SRRC)
timeFrame: 2 weeks and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Panti Sosial Tresna Werdha Budi Mulia 3
state: DKI Jakarta
Study officials:
affiliation: Faculty of Medicine, University of Indonesia
name: Parikesit Muhammad, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.