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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Philippines
VMV Skin Research Center & Clinics
RECRUITING
Makati City
Contact Information
Primary
Cristina C Verallo Rowell, MD, MBA
ccvrowell@gmail.com
639171478318
Backup
Vermen M Verallo-Rowell, MD
vmvrmd@gmail.com
639178373134
Time Frame
Start Date: 2025-08-31
Estimated Completion Date: 2025-10
Participants
Target number of participants: 26
Treatments
Experimental: Right Arm: Applying Test Product
No_intervention: Left Arm: Applying no topicals
Active_comparator: Petrolatum: Right Arm: Applying Petrolatum
Sponsors
Leads: Makati Medical Center

This content was sourced from clinicaltrials.gov