Moisturizer for Acne

Overseen By Kenvue Global Clinical Operations

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kenvue Brands LLC

Must be taking: Benzoyl peroxide, Retinoids, Antibiotics, Epiduo

Must not be taking: Steroids, NSAIDs, Antihistamines, Accutane

Disqualifiers: Severe acne, Diabetes, Immunosuppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new facial moisturizer, specifically a Barrier Building Moisturizer, to evaluate its effectiveness and skin-friendliness for individuals with mild to moderate acne. Participants should have used acne treatments like creams or gels for at least a month and be willing to continue during the study. It suits those with a stable acne routine and generally good health. As an unphased trial, this study provides a unique opportunity to contribute to skincare research and potentially enhance acne management routines.

Do I have to stop taking my current medications for the trial?

No, you don't have to stop your current acne medications. In fact, you need to continue your usual treatment without changes during the study. However, certain other medications like oral isotretinoin (Accutane) and some others listed in the exclusion criteria are not allowed.

What prior data suggests that this moisturizer is safe for acne treatment?

Research has shown that the Barrier Building Moisturizer has undergone testing for safety, stability, and effectiveness. It is considered safe for use on the skin, meaning it is unlikely to cause harm or severe reactions when used as directed. Apply the moisturizer only to the skin and avoid contact with the eyes, nose, and mouth. While side effects are rare, rinse the affected area with water if any irritation occurs. Overall, the moisturizer is well-tolerated and serves as a safe option for those with mild to moderate acne. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for acne, like benzoyl peroxide and salicylic acid, focus on reducing oil or killing bacteria. However, the barrier-building moisturizer is unique because it aims to strengthen the skin's natural barrier, which can reduce irritation and inflammation. This approach is gentler on the skin, making it suitable for people with sensitive skin or those who experience dryness from traditional acne treatments. Researchers are excited about this treatment because it offers a novel way to manage acne by supporting the skin's health, potentially leading to clearer skin without harsh side effects.

What evidence suggests that this moisturizer might be an effective treatment for acne?

Research has shown that people with acne often experience higher levels of transepidermal water loss (TEWL), meaning their skin loses moisture more easily. One study found that a moisturizer designed to strengthen the skin's barrier can significantly improve skin hydration and reduce moisture loss. Another study demonstrated that after 60 days of using a moisturizer specifically for acne, skin moisture noticeably improved. These findings suggest that a moisturizer aimed at strengthening the skin barrier might help manage acne by maintaining hydration and reducing dryness and irritation. Participants in this trial will use a Barrier Building Moisturizer to evaluate its effectiveness in improving skin hydration and managing acne symptoms. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with mild to moderate acne vulgaris who are interested in testing a facial moisturizer designed for acne-prone skin over four weeks. Specific eligibility criteria details were not provided.

Inclusion Criteria

Skin types V or VI: 30-40% of enrolled subjects

Fitzpatrick Skin Type of I to VI

Skin types I, II, III, or IV: 60-70% of enrolled subjects

Exclusion Criteria

Is simultaneously participating in any other product-use study or has participated in any clinical study on the face in the past 4 weeks

Is self-reported to be pregnant, breastfeeding, or planning to become pregnant during the study or within 30 days of study completion

Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants use a facial moisturizer to evaluate tolerance and efficacy over a 4-week period

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Barrier Building Moisturizer

Trial Overview

The study aims to assess the tolerability and effectiveness of a 'Barrier Building Moisturizer' when used by people with mild to moderate acne over a period of one month.

How Is the Trial Designed?

Group I: Experimental group: Moisturizer Use Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Kenvue Brands LLC

Lead Sponsor

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11537166/

Skin Barrier Parameters in Acne Vulgaris versus Normal ...

Results from this study show that patients with acne vulgaris have significantly higher TEWL, sebum and hydration. The elevations of TEWL and ...

2.

jaad.org

jaad.org/article/S0190-9622(25)01917-6/fulltext

62324 Skin Barrier Cream: Evaluation of the Efficacy and ...

Statistically significant improvements were observed on visible dry areas, visible redness, hydration, and TEWL as early as 3 days and persisted throughout the ...

3.

cosmoderma.org

cosmoderma.org/skin-moisturizing-and-anti-acne-effect-of-acne-moisturizer-in-healthy-adult-subjects-with-mild-to-moderate-acne-an-open-label-single-arm-clinical-study/

Skin moisturizing and anti-acne effect of acne ... - Cosmoderma

After using Acne Moisturizer for 60 days, statistically significant (P < 0.0001) improvement from baseline was observed in skin moisturization.

4.

jddonline.com

jddonline.com/articles/efficacy-consumer-perception-of-topical-over-counter-regimens-involving-beta-hydroxy-acid-acne-vulgaris-S1545961625P8502X

Efficacy and Consumer Perception of Topical Over-the- ...

This article presents an analysis from a single-center, open-label study with 20 participants conducted to evaluate if an over-the-counter (OTC) barrier- ...

5.

dermatologytimes.com

dermatologytimes.com/view/patients-treated-for-acne-exhibit-higher-sebum-hydration-and-tewl-levels-than-general-population

Patients Treated for Acne Exhibit Higher Sebum, Hydration, ...

Acne vulgaris patients show elevated TEWL, sebum production, and skin hydration, with medication users experiencing further barrier impairments.

6.

images.thdstatic.com

images.thdstatic.com/catalog/pdfImages/5a/5a03ab54-12f6-48dd-84ec-6123251435e8.pdf

Skin Barrier Cream

Skin protection: None required. Wear protective clothing and protective boots if the situation requires. Upper Explosive Limit (UEL). No data ...

7.

medline.com

medline.com/media/catalog/Docs/MSDS/MSD_SDSD12211.pdf

Safety Data Sheet

Refer to other sections of this SDS for information regarding physical and health hazards, respiratory protection, ventilation, and personal ...

8.

colorescience.com

colorescience.com/products/barrier-pro-essential-moisturizer?srsltid=AfmBOopnawvIyxPxBjfV4YljSwnUmXmJtOKwAzNXUTO_WPeMqh12eVng

Barrier Pro™ Essential Moisturizer

This product has been tested for safety, stability and efficacy and is safe for use on the skin. For external use only -- keep out of eyes, nose and mouth.

9.

spaldings.co.uk

spaldings.co.uk/Files/Files/Downloads/Data%20Sheets/08373%20MSDS%20Barrier%20Cream.pdf

Safety Data Sheet For 08373 – Universal Barrier Cream

FIRST AID MEASURES. Eye Contact: Flush with plenty of clean water for at least 15 minutes. If irritation persists obtain medical attention. Skin Contact:.

10.

workshopwarehouse.co.uk

workshopwarehouse.co.uk/downloads/dl/file/id/1731/vc500a.pdf

SAFETY DATA SHEET Barrier Cream

Personal precautions. Wear protective clothing as described in Section 8 of this safety data sheet. In case of spills, beware of slippery floors and surfaces.