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

Xerosis Cutis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06178367
• Other study ID #: 23061046
• Status: Completed
• Phase: Phase 3
• Start date: August 26, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: April 2024
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Xerosis Cutis

Intervention

Drug:
• Low molecular weight hyaluronic acid
Topical 0,1% low molecular weight (7 kDa) hyaluronic acid in vehicle
• High molecular weight hyaluronic acid
Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid in vehicle
• 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

Locations

Country	Name	City	State
Indonesia	Panti Sosial Tresna Werdha Budi Mulia 3	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin capacitance	Skin capacitance is measured by Corneometer CM825	2 weeks and 4 weeks
Primary	Transepidermal water loss	Transepidermal water loss is measured by Tewameter TM300	2 weeks and 4 weeks
Primary	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