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

Phase 3

Completed

• Conditions: Xerosis Cutis
• Interventions: Drug: Vehicle; Drug: High molecular weight hyaluronic acid; Drug: Low molecular weight hyaluronic acid

• Registration Number: NCT06178367
• Lead Sponsor: Indonesia University

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?

Study Timeline

• Study Start: 2023-08-26
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Study First Submitted: 2023-12-10
• Study First Submitted QC: 2023-12-10
• Study First Posted: 2023-12-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-26
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid	High molecular weight 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
Topical 0,1% low molecular weight (7 kDa) hyaluronic acid	Low molecular weight 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

Primary Outcome Measures

Name	Time	Method
Skin capacitance	2 weeks and 4 weeks	Skin capacitance is measured by Corneometer CM825
Specified symptom sum score/scale, roughness, redness, crack (SRRC)	2 weeks and 4 weeks	Evaluation of squama/scale, roughness, redness, and crack of the skin, with a value range of 0-16. Higher values mean worse outcome
Transepidermal water loss	2 weeks and 4 weeks	Transepidermal water loss is measured by Tewameter TM300

Trial Locations

Locations (1)

Panti Sosial Tresna Werdha Budi Mulia 3; 🇮🇩 Jakarta, DKI Jakarta, Indonesia