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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-26

Study Completion Date

2023-09-30

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

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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:

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?

Conditions

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Xerosis Cutis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

All moisturizers used in this clinical trial were made in the same preparation and packaging

Study Groups

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Topical 0,1% low molecular weight (7 kDa) hyaluronic acid

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

Group Type EXPERIMENTAL

Low molecular weight hyaluronic acid

Intervention Type DRUG

Topical 0,1% low molecular weight (7 kDa) hyaluronic acid in vehicle

Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid

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

Group Type ACTIVE_COMPARATOR

High molecular weight hyaluronic acid

Intervention Type DRUG

Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid in vehicle

Vehicle

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.

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type 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

Interventions

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Low molecular weight hyaluronic acid

Topical 0,1% low molecular weight (7 kDa) hyaluronic acid in vehicle

Intervention Type DRUG

High molecular weight hyaluronic acid

Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid in vehicle

Intervention Type DRUG

Vehicle

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

Intervention Type DRUG

Other Intervention Names

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LMWHA HMWHA Placebo

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

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No