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

University of Indonesia (UI)

Status and phase: Completed; Phase 3

Conditions: Xerosis Cutis

Treatments: Drug: Low molecular weight hyaluronic acid; Drug: High molecular weight hyaluronic acid; Drug: Vehicle

Study type: Interventional

Funder types: Other

Identifiers

NCT06178367

23061046

Details and patient eligibility

About

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

Full 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?

Enrollment: 36 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: Low molecular weight hyaluronic acid

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

Active Comparator group

Description:

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

Treatment:

Drug: High molecular weight hyaluronic acid

Vehicle

Placebo Comparator group

Description:

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.

Treatment:

Drug: Vehicle