RECRUITINGINTERVENTIONAL

Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction

A Pilot Double-Blind Randomized Controlled Trial on the Efficacy and Safety of a Novel Skin Barrier Product Versus Petrolatum in Individuals With Skin Barrier Dysfunction

About This Trial

The goal of this clinical trial is to learn if a novel barrier topical product works to treat barrier dysfunction in adults. It will also learn about the safety of the novel barrier topical product. The main questions it aims to answer are: Does the novel barrier topical product improve skin hydration, skin sebum, redness, and pigmentation? Does it improve subjective dryness and itch? Researchers will compare the novel barrier topical product to petrolatum (a gold standard occlusive barrier repair agent) to see how they are comparable in treating skin barrier dysfunction. Participants will: Apply the novel barrier topical product or petrolatum twice a day for 28 days Visit the clinic once a week for checkups and tests Keep a diary of their application of the assigned product

Who May Be Eligible (Plain English)

Who May Qualify: - Clinical diagnosis of mild skin barrier dysfunction, including: - Mild to moderate atopic dermatitis, defined as SCORAD ≤ 50, and/or not currently requiring topical corticosteroids or immunomodulators. - Mild to moderate chronic plaque psoriasis, defined as total body surface area (BSA) involved: ≤3% to 10%. - Contact dermatitis - Seasonal xerosis or clinically evident skin dryness - Symmetrical or bilateral test areas available (volar forearm) - Willing and able to provide willing to sign a consent form and adhere to study procedures Who Should NOT Join This Trial: - Failure to meet any of the above inclusion criteria - Severe atopic dermatitis or psoriasis requiring systemic or high-potency topical treatment - Use of corticosteroids, calcineurin inhibitors, biologics, or phototherapy within 2 weeks - Open wounds or evidence of secondary infection at test sites - Pregnant or breastfeeding women - Multiple nevi, tattoos, dense body hair in the test areas - Debilitated or immunocompromised subjects - Known or suspected hypersensitivity to the interventional product (or its ingredients) or petrolatum - Refusal or failure to comply with the schedule of visits at the test site. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Clinical diagnosis of mild skin barrier dysfunction, including: * Mild to moderate atopic dermatitis, defined as SCORAD ≤ 50, and/or not currently requiring topical corticosteroids or immunomodulators. * Mild to moderate chronic plaque psoriasis, defined as total body surface area (BSA) involved: ≤3% to 10%. * Contact dermatitis * Seasonal xerosis or clinically evident skin dryness * Symmetrical or bilateral test areas available (volar forearm) * Willing and able to provide informed consent and adhere to study procedures Exclusion Criteria: * Failure to meet any of the above inclusion criteria * Severe atopic dermatitis or psoriasis requiring systemic or high-potency topical treatment * Use of corticosteroids, calcineurin inhibitors, biologics, or phototherapy within 2 weeks * Open wounds or evidence of secondary infection at test sites * Pregnant or breastfeeding women * Multiple nevi, tattoos, dense body hair in the test areas * Debilitated or immunocompromised subjects * Known or suspected hypersensitivity to the interventional product (or its ingredients) or petrolatum * Refusal or failure to comply with the schedule of visits at the test site.

Treatments Being Tested

OTHER

Novel barrier repair topical product

Novel barrier product (containing ceramide, virgin coconut oil, cholesterol)

OTHER

Petrolatum

Petrolatum application

Locations (1)

VMV Skin Research Center & Clinics

Makati City, National Capital Region, Philippines