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

NCT06178367 | Completed Phase 3

• 1 other identifier: 23061046
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Xerosis Cutis

Outcome Measures

Primary Outcomes (3)

• Skin capacitance

  Skin capacitance is measured by Corneometer CM825

  2 weeks and 4 weeks

• Transepidermal water loss

  Transepidermal water loss is measured by Tewameter TM300

  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

  2 weeks and 4 weeks

Study Arms (3)

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

EXPERIMENTAL

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% high molecular weight (1.800 kDa) hyaluronic acid

ACTIVE COMPARATOR

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

Drug: High molecular weight hyaluronic acid

Vehicle

PLACEBO COMPARATOR

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

Interventions

Low molecular weight hyaluronic acid DRUG

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

Also known as: LMWHA

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

High molecular weight hyaluronic acid DRUG

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

Also known as: HMWHA

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

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

Also known as: Placebo

Vehicle

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male diagnosed with xerotic skin
• years old
• Willing to participate in clinical trial and sign informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Panti Sosial Tresna Werdha Budi Mulia 3

Jakarta, DKI Jakarta, 12420, Indonesia

Location

Related Publications (3)

• 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.

  PMID: 22052267 RESULT

• 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.

  PMID: 36074117 RESULT

• Muhammad P, Novianto E, Setyorini M, Legiawati L, Yusharyahya SN, Menaldi SL, Budianti WK. Effectiveness of topical hyaluronic acid of different molecular weights in xerosis cutis treatment in elderly: a double-blind, randomized controlled trial. Arch Dermatol Res. 2024 Jun 3;316(6):329. doi: 10.1007/s00403-024-03003-2.

  PMID: 38829483 DERIVED

Study Officials

• Parikesit Muhammad, MD

  Faculty of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All moisturizers used in this clinical trial were made in the same preparation and packaging
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology and Venereology Resident

Model Details: This is a split study, one participant receive three interventions in three area in the leg. The distribution of treatment groups is carried out randomly using the block randomization method.

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: December 21, 2023
• Study Start: August 26, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)