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Completed

NCT Number: NCT06178367

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

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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Key information

Conditions

Xerosis Cutis

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Panti Sosial Tresna Werdha Budi Mulia 3

Jakarta, DKI Jakarta, 12420, Indonesia

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Molecular Weight Hyaluronic Acid

Drug

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

Other names: LMWHA

High molecular weight hyaluronic acid

Drug

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

Other names: HMWHA

Vehicle

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

Other names: Placebo

Primary outcomes

  1. Skin capacitance

    Time frame: 2 weeks and 4 weeks

    Skin capacitance is measured by Corneometer CM825

  2. Transepidermal water loss

    Time frame: 2 weeks and 4 weeks

    Transepidermal water loss is measured by Tewameter TM300

  3. Specified symptom sum score/scale, roughness, redness, crack (SRRC)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 21, 2023
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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