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

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

Study Overview

• Status: Recruiting
• Conditions: Psoriasis; Atopic Dermatitis; Contact Dermatitis; Xerosis
• Intervention / Treatment: Other: Novel barrier repair topical product; Other: Petrolatum

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina C Verallo Rowell, MD, MBA; Phone Number: 639171478318; Email: ccvrowell@gmail.com
• Study Contact Backup: Name: Vermen M Verallo-Rowell, MD; Phone Number: 639178373134; Email: vmvrmd@gmail.com

Study Locations

• Philippines
  • National Capital Region
    • Makati City, National Capital Region, Philippines, 1229
      • Recruiting
      • VMV Skin Research Center & Clinics
      • Contact: Danielle Besa; Phone Number: 639665394196‬; Email: dbesa@vmvgroup.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Right Arm: Applying Test Product	Other: Novel barrier repair topical product; Novel barrier product (containing ceramide, virgin coconut oil, cholesterol)
No Intervention: Left Arm: Applying no topicals
Active Comparator: Petrolatum: Right Arm: Applying Petrolatum	Other: Petrolatum; Petrolatum application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transepidermal water loss	using a Tewameter	28 days
Skin hydration	Using a Corneometer	28 days
Skin sebum	Using a Sebumeter	28 days
Skin erythema and pigmentation	Using a Mexameter	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in dryness	Measured by Visual Analog Scale	28 days
Change in itch	Measured by Visual Analog Scale	28 days
Ease in application	Using Patient Satisfaction Questionnaire	28 days
Skin softness and smoothness	Patient Satisfaction Questionnaire	28 days
Satisfaction with product	Using Patient Satisfaction Questionnaire	28 days

Collaborators and Investigators

• Sponsor: Makati Medical Center
• Investigators: Principal Investigator: Vermen M Verallo Rowell, MD, VMV Skin Research Center & Clinics

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 14, 2025
• First Submitted That Met QC Criteria: September 14, 2025
• First Posted (Estimated): September 19, 2025

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 14, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Ceramides; Skin care; Coconut oil; Emollients; Epidermis/Injuries
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Papulosquamous; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Wounds and Injuries; Psoriasis; Dermatitis, Atopic; Dermatitis, Contact; Organic Chemicals; Hydrocarbons; Petrolatum
• Other Study ID Numbers: MMCIRB2025-06-91

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data obtained through this study may be provided to qualified researchers with academic interest in skin barrier defects and tropical barrier products. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• IPD Sharing Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact ccvrowell@gmail.com.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No