A Clinical In-Use Evaluation to Assess the Tolerability and Efficacy of a Moisturizer on Acne Prone Skin

Kenvue Brands LLC

Status: Completed

Conditions: Acne Vulgaris

Treatments: Other: Use of Barrier Building Moisturizer

Study type: Interventional

Funder types: Industry

Identifiers

NCT07224633

CS2025SK100252

Details and patient eligibility

About

The objective of this study is to evaluate the tolerance and efficacy of a facial moisturizer in subjects with mild to moderate acne vulgaris over a 4-week treatment period.

Enrollment: 47 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Fitzpatrick Skin Type of I to VI, targeting the following:

   1. Skin types I, II, III, or IV: 60-70% of enrolled subjects
   2. Skin types V or VI: 30-40% of enrolled subjects

2. Has acne as determined by PI and is undergoing current stable, daily treatment of acne for at least one month prior to study initiation.

   a. Treatments may include but are not limited to, either prescription or over-the counter products, such as: Benzoyl Peroxide, Retinoids (Adapalene, Tretinoin, Tazarotene), Topical Antibiotics and oral antibiotics (if used at least 30 days prior to Visit 1), Topical Dapsone, and Epiduo. Note: use of oral isotretinoin (Accutane) is prohibited. Targeting up to 20 subjects currently using a prescription treatment.

3. Willing to continue his/her normal course of treatment (used at least 30 days prior to Visit 1), for their skin condition with no changes during the study.

4. Generally, in good health based on medical history reported by the subject.

5. Able to read, write, speak, and understand English

6. Individuals have signed the ICD including the photo release and Health Insurance Portability and Accountability Act (HIPAA) disclosure

7. Intends to complete the study and is willing and able to follow the subject responsibilities.

Exclusion criteria

1. Has severely sensitive skin and/or has known allergies or adverse reactions to common topical skincare products or to ingredients in the IP or has demonstrated a previous hypersensitivity reaction to any of the ingredients in the IP.

2. Has a clinically significant, unstable medical disorder(s)

3. Is unwilling or unable to comply with the requirements of the protocol.

4. Has a history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.

5. Has any surgery and/or invasive medical procedure planned during the course of the study.

6. Has started a hormone replacement therapy (HRT) or hormonal birth control less than 3 months prior to Visit 1 or plans on starting, stopping, or changing doses of HRT or hormonal birth control during the study

7. Presents with a pre-existing or dormant facial dermatologic condition that, in the PI or designee's opinion, may confound the study results or otherwise be inappropriate for study participation (e.g., severe acne, acne conglobata, psoriasis, rashes, skin cancer, many and/or severe excoriations, observable suntan, scars, nevi, tattoo, excessive hair, etc.)

8. Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.

9. Is taking/using medications or a product that would mask an adverse event (AE) or influence the study results, including:

   1. Steroidal drugs within 2 months before Visit 1
   2. Non-steroidal anti-inflammatory drugs within 5 days before Visit 1
   3. Antihistamines within 2 weeks before Visit 1
   4. Oral isotretinoin (Accutane) within 6 months to Visit 1
   5. Anticancer and immunosuppressive treatments/medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, Remicade, Stelara) currently or within 3 months before Visit 1
   6. Radiation currently or within 1 week before Visit 1

10. Has a history of or a concurrent health condition/situation which, in the opinion of the PI may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study.

11. Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS).

12. Is participating in or planning to receive any professional or aesthetic facial spa procedures during the study.

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

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

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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47 participants in 1 patient group

Experimental group: Moisturizer Use

Experimental group

Treatment:

Other: Use of Barrier Building Moisturizer