Novel Skin Barrier Product Versus Petrolatum for Skin Barrier Dysfunction

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое Novel barrier repair topical product
  Novel barrier product (containing ceramide, virgin coconut oil, cholesterol)
• Другое Petrolatum
  Petrolatum application

Первичные конечные точки

• Transepidermal water loss [Срок оценки: 28 days]
• Skin hydration [Срок оценки: 28 days]
• Skin sebum [Срок оценки: 28 days]
• Skin erythema and pigmentation [Срок оценки: 28 days]

Вторичные конечные точки (5)

• Change in dryness [Срок оценки: 28 days]
• Change in itch [Срок оценки: 28 days]
• Ease in application [Срок оценки: 28 days]
• Skin softness and smoothness [Срок оценки: 28 days]
• Satisfaction with product [Срок оценки: 28 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Филиппины · 1 центр

• VMV Skin Research Center & Clinics — Makati City

Идентификаторы

NCT: NCT07183423 · MMCIRB2025-06-91

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗