New ceramide‑and‑coconut‑oil skin barrier cream versus petrolatum for dry or irritated skin
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
This study will test whether a new ceramide- and coconut oil–based cream can improve skin hydration and reduce dryness and itch in adults with mild to moderate psoriasis, atopic dermatitis, contact dermatitis, or xerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Makati Medical Center Academic / other |
| Locations | 1 site (Makati City, National Capital Region) |
| Trial ID | NCT07183423 on ClinicalTrials.gov |
What this trial studies
This pilot randomized controlled trial compares a novel topical barrier product (containing ceramides, cholesterol, virgin coconut oil, and monolaurin) with petrolatum in adults who have mild-to-moderate skin barrier dysfunction. Participants will apply the assigned product twice daily to symmetrical forearm sites for 28 days and attend weekly clinic visits for measurements. Primary outcomes are objective measures of barrier function and skin condition—transepidermal water loss (Tewameter), skin hydration (Corneometer), skin lipids (Sebumeter), and erythema/pigmentation (Mexameter)—collected at baseline and weeks 1, 2, and 4. Secondary outcomes include patient-reported dryness and itch on visual analogue scales, treatment comfort and satisfaction, and monitoring of adverse skin reactions.
Who should consider this trial
Good fit: Adults with mild to moderate psoriasis, atopic dermatitis, contact dermatitis, or seasonal xerosis who have symmetrical forearm test areas and are not using recent topical or systemic immunomodulators are ideal candidates.
Not a fit: Patients with severe disease that requires systemic or high‑potency topical therapy, those with open or infected test site wounds, pregnant or breastfeeding women, or people unable to attend weekly clinic visits are unlikely to receive benefit from this study.
Why it matters
Potential benefit: If successful, the product could improve skin hydration, reduce dryness and itch, and offer a well-tolerated alternative or complement to petrolatum for people with mild barrier dysfunction.
How similar studies have performed: Ceramide-containing moisturizers have previously shown benefit for barrier repair, while the specific combination with coconut oil and monolaurin in this formulation is relatively novel and under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Makati City, National Capital Region
- VMV Skin Research Center & Clinics — Makati City, National Capital Region, Philippines (Recruiting)
Study contacts
- Principal investigator: Vermen M Verallo Rowell, MD — VMV Skin Research Center & Clinics
- Study coordinator: Cristina C Verallo Rowell, MD, MBA
- Email: ccvrowell@gmail.com
- Phone: 639171478318
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.