## Protocol Section
### Identification Module
**NCT ID:** NCT06415292

**Brief Title:** A Study to Evaluate the Impact of Clacoterone 1% Cream on Skin Barrier Properties in Acne Prone Patients

**Official Title:** A Clinical Study to Assess the Barrier Impact of Winlevi

#### Organization Study ID Info
**ID:** DCS-94-23
#### Organization
**Class:** INDUSTRY
**Full Name:** Sun Pharmaceutical Industries Limited
### Status Module
#### Completion Date
**Date:** 2023-12-16

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-16

**Type:** ACTUAL

#### Start Date
**Date:** 2023-11-27

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sun Pharmaceutical Industries Limited

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Acne medications are a common source of facial dryness resulting in skin barrier damage and poor patient compliance. Retinoids and benzoyl peroxide are some of the most frequently prescribed and effective acne medications, however, dryness is an unwanted side effect. A new acne medication, 1% clascoterone, has been placed in a novel vehicle for excellent drug delivery in combination with excellent barrier properties. The barrier properties of 1% clascoterone have never been demonstrated. This study is aimed at better understanding the positive barrier effects of 1% clascoterone.

### Conditions Module

**Conditions:**

- Acne Vulgaris

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Winlevi (clascoterone) 1% cream

**Label:** Winlevi (clascoterone) 1% treated

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Winlevi (clascoterone) 1% treated

**Description:** Split face. Blinded study treatment product to be applied to the randomized half face

**Name:** Winlevi (clascoterone) 1% cream

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** The primary endpoint is the change in corneometry reading between the two sides of the face treated with Winlevi versus no treatment.

**Time Frame:** Week 2

#### Secondary Outcomes

**Measure:** The secondary endpoint is the change in TEWL reading between the two sides of the face treated with Winlevi versus no treatment

**Time Frame:** Week 2

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Subjects who self identify as having sensitive acne prone skin.
2. Female or male subjects 18+ years of age.
3. Subjects with Fitzpatrick skin types I-VI.
4. Subject agrees not to introduce any new colored cosmetics (lipsticks, eye shadows, facial foundations, blush, powder) or skin care products during the study.
5. Subjects must be willing to use only a cleanser and sunscreen on the entire face and no other skin care products.
6. Subjects must be willing to use the Winlevi study product to designated half face. No other topical acne treatment products on the entire face for the 2 week duration of the study.
7. Subject has signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects."
8. Subject is dependable and able to follow directions and is willing to comply with the schedule of visits.
9. Subject is in generally good physical and mental health.

Exclusion Criteria:

1. Any dermatological disorder, which in the investigator's opinion, may interfere with the accurate evaluation of the subject's skin characteristics, except for the conditions associated with sensitive skin.
2. Subjects who are not willing to use only the assigned study product and nothing else one randomized half face, except for cleanser and sunscreen that must remain unchanged during the study. Moisturizers or topical acne treatment products should not be used during the 2 week study period on either side of the face.
3. Subjects who do not agree to refrain from direct sun exposure during the study duration.
4. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
5. Subjects, who are pregnant, breast feeding, or planning a pregnancy.
6. Subjects with clinically significant unstable medical disorders.
7. Subjects who are unwilling or unable to comply with the requirements of the protocol.
8. Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study.
9. Subjects who are currently participating in any other clinical study.
10. Subjects with any planned surgeries and/or invasive medical procedures during the course of the study.
11. Subjects who currently or frequently use high doses of anti-inflammatory drugs for a defined medication condition. Aspirin use should not exceed 2 tablets (650 mg) per day.
12. Subjects currently receiving any anticancer, immunosuppressive treatments/ medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.), or radiation as determined by the initial paperwork.
13. Subjects with a history of immunosuppression/immune deficiency disorders (including (HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara) and/or radiation as determined by study documentation.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** High Point

**Country:** United States

**Facility:** Dermatology Consulting Services, PLLC

**State:** North Carolina

**Zip:** 27262

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000017486

- Term: Acneiform Eruptions

- ID: D000012871

- Term: Skin Diseases

- ID: D000012625

- Term: Sebaceous Gland Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M3512

- Name: Acne Vulgaris

- Relevance: HIGH

- As Found: Acne Vulgaris

- ID: M8219

- Name: Exanthema

- Relevance: LOW

- As Found: Unknown

- ID: M19751

- Name: Acneiform Eruptions

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15439

- Name: Sebaceous Gland Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000152

- Term: Acne Vulgaris

### Misc Info Module

- Version Holder: 2024-05-31
