Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction

NCT07183423 | Recruiting

• 1 other identifier: MMCIRB2025-06-91
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis; Atopic Dermatitis; Xerosis; Contact Dermatitis

Keywords

Ceramides; Emollients; Skin care; Epidermis/Injuries; Coconut oil

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Change in dryness

  28 days

• Change in itch

  28 days

• Ease in application

  28 days

• Skin softness and smoothness

  28 days

• Satisfaction with product

  28 days

Study Arms (3)

Right Arm: Applying Test Product

EXPERIMENTAL

Other: Novel barrier repair topical product

Left Arm: Applying no topicals

NO INTERVENTION

Petrolatum: Right Arm: Applying Petrolatum

ACTIVE COMPARATOR

Other: Petrolatum

Interventions

Novel barrier repair topical product OTHER

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

Right Arm: Applying Test Product

Petrolatum OTHER

Petrolatum application

Petrolatum: Right Arm: Applying Petrolatum

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Makati Medical Center: lead

Study Sites (1)

VMV Skin Research Center & Clinics

Makati City, National Capital Region, 1229, Philippines

RECRUITING

MeSH Terms

Conditions

Psoriasis; Dermatitis, Atopic; Dermatitis, Contact; Wounds and Injuries

Interventions

Petrolatum

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Officials

• Vermen M Verallo Rowell, MD

  VMV Skin Research Center & Clinics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina C Verallo Rowell, MD, MBA

CONTACT

639171478318; ccvrowell@gmail.com

Vermen M Verallo-Rowell, MD

CONTACT

639178373134; vmvrmd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Past Chairman of Dermatology, Current Active Consultant

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 19, 2025
• Study Start: August 31, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• 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.
• 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.

Locations

PH (1)