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

December 26, 2023 updated by: Parikesit Muhammad, Indonesia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 12420
        • Panti Sosial Tresna Werdha Budi Mulia 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Low molecular weight hyaluronic acid
Topical 0,1% low molecular weight (7 kDa) hyaluronic acid in vehicle
Other Names:
  • LMWHA
Active Comparator: Topical 0,1% high molecular weight (7 kDa) hyaluronic acid
Participants receive moisturizer containing 0,1% high 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
Drug: High molecular weight hyaluronic acid
Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid in vehicle
Other Names:
  • HMWHA
Placebo Comparator: 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.
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
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin capacitance
Time Frame: 2 weeks and 4 weeks
Skin capacitance is measured by Corneometer CM825
2 weeks and 4 weeks
Transepidermal water loss
Time Frame: 2 weeks and 4 weeks
Transepidermal water loss is measured by Tewameter TM300
2 weeks and 4 weeks
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
2 weeks and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Parikesit Muhammad, MD, Faculty of medicine, University of Indonesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

December 10, 2023

First Submitted That Met QC Criteria

December 10, 2023

First Posted (Actual)

December 21, 2023

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23061046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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