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

Indonesia University36 enrolled

Overview

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: 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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Xerosis Cutis

Interventions

Low molecular weight hyaluronic acidDRUG

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

High molecular weight hyaluronic acidDRUG

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

VehicleDRUG

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

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Panti Sosial Tresna Werdha Budi Mulia 3

Jakarta, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

Skin capacitance

Skin capacitance is measured by Corneometer CM825

Time frame: 2 weeks and 4 weeks

Transepidermal water loss

Transepidermal water loss is measured by Tewameter TM300

Time frame: 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

Time frame: 2 weeks and 4 weeks

Data from ClinicalTrials.gov

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