Xerosis Cutis
Conditions
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
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?
Interventions
Topical 0,1% low molecular weight (7 kDa) hyaluronic acid in vehicle
DRUGHigh molecular weight hyaluronic acid
Topical 0,1% high molecular weight (1.800 kDa) hyaluronic acid in vehicle
DRUGVehicle
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
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All moisturizers used in this clinical trial were made in the same preparation and packaging
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin capacitance | 2 weeks and 4 weeks | Skin capacitance is measured by Corneometer CM825 |
| Transepidermal water loss | 2 weeks and 4 weeks | Transepidermal water loss is measured by Tewameter TM300 |
| Specified symptom sum score/scale, roughness, redness, crack (SRRC) | 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 |
Countries
Indonesia
Outcome results
None listed