Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction

Makati Medical Center

Status

Enrolling

Conditions

Atopic Dermatitis

Psoriasis

Xerosis

Contact Dermatitis

Treatments

Other: Petrolatum

Other: Novel barrier repair topical product

Study type

Interventional

Funder types

Other

Identifiers

NCT07183423

MMCIRB2025-06-91

Details and patient eligibility

About

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

Full description

The goal of this randomized controlled trial is to determine the efficacy of a new barrier product (containing ceramide, virgin coconut oil, cholesterol) versus petrolatum in adults with skin barrier dysfunction (including mild to moderate psoriasis, atopic dermatitis, contact dermatitis, seasonal xerosis or clinically evident skin dryness).

The main questions it aims to answer are:

Primary Objective: In a pilot study, to compare the preliminary effectiveness of the test product (containing ceramides, cholesterol, coconut oil and monolaurin) versus petrolatum in improving skin barrier function, as measured by transepidermal water loss (using a Tewameter), skin hydration (using a Corneometer), skin lipids (using a Sebumeter) as well as skin erythema and pigmentation (using a Mexameter) over a four-week period.

Secondary Objectives:

To assess improvement in subjective symptoms (dryness, pruritus). To assess patient-reported outcomes, including comfort, ease of application, and overall satisfaction.

To monitor and compare any adverse events or skin reactions associated with both treatments.

Researchers will compare versus petrolatum to see if effects are comparable. Participants will upon enrollment to the study, be asked to accomplish the Personal Information Sheet and Patient Satisfaction Questionnaire. They will be taught how to mark the Visual Analogue Scale according to the degree of dryness and itch felt. They will accomplish this at Baseline, weeks 1, 2 and 4.

Non-invasive measurements will be done of: skin hydration (using Tewameter and Corneometer), skin sebum (using Sebumeter) and skin redness/pigmentation (using Mexameter) at baseline, weeks 1, 2, and 4. Pictures will also be taken of the test area at each visit.

All participants will be given a 1 or 3-week supply of either the test medication or the placebo in identical jars, color, and smell to maintain blinding. Refills will be given at each follow-up. Written instructions on how to use them will also be provided. The product will be applied twice daily on the right forearm for 28 days. The amount applied will be ⅛ teaspoon per application, with a plastic measuring spoon given for their use. They will be instructed not to apply the product to any other location. They will also be advised on the possible adverse effects and will be instructed to contact the investigator in case an adverse reaction happens. They will then be instructed to follow up after 1, 2, and 4 weeks.

Enrollment

26 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.