Effectiveness and Safety of Topical Hyaluronic Acid of Different Molecular Weights in Xerotic Skin Treatment

Study Overview
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Brief Summary
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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

Detailed Description
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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: 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? 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? 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? 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?

Official Title
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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

Conditions
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Xerosis Cutis

Intervention / Treatment
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* Drug: Low molecular weight hyaluronic acid
* Drug: High molecular weight hyaluronic acid
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical 0,1% low molecular weight (7 kDa) hyaluronic acid<br>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 | Drug: Low molecular weight hyaluronic acid<br>* Topical 0,1% low molecular weight (7 kDa) hyaluronic acid in vehicle<br>* Other names: LMWHA;|
| Active Comparator: Topical 0,1% high molecular weight (7 kDa) hyaluronic acid<br>Participants receive moisturizer containing 0,1% high 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 | Drug: High molecular weight hyaluronic acid<br>* Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid in vehicle<br>* Other names: HMWHA;|
| Placebo Comparator: Vehicle<br>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. | Drug: Vehicle<br>* 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<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |