## Protocol Section
### Identification Module
**NCT ID:** NCT06415305

**Brief Title:** A Study Evaluating the Efficacy and Safety of Clascoterone Cream 1% in Skin of Color Patients With Acne

**Official Title:** The Efficacy and Safety of Winlevi in Skin of Color Patients With Acne

#### Organization Study ID Info
**ID:** WINSCO - 2023
#### Organization
**Class:** INDUSTRY
**Full Name:** Sun Pharmaceutical Industries Limited
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

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

**Type:** ACTUAL

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

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-09-01

**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 vulgaris is the most common skin disease in patients with skin of color and second most common in Caucasian population. The global prevalence is thought to be as high as 60-80% in individuals 12-25 years of age. However, it is not limited to only teenagers but also to adults, especially adult females. The pathogenesis of acne is multifactorial. Genetics may also play a role. The treatment pathway should be directed to different pathogenic factors including, excessive sebum production, hyper keratinization, P. acnes, and inflammation.

Data is limited for skin of color patients in Phase III registration trials. Data is limited because there a few studies that focus on patients with skin of color. Therefore, a unique study dedicated to patients with skin of color in a real-world setting will be welcome to add further evidence to phase III data.

### 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:** 10

**Type:** ESTIMATED

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Winlevi (clascoterone) 1% cream

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

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Winlevi (clascoterone) 1% cream

**Description:** Dosed twice daily (BID)

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

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16.

**Time Frame:** Week 16

#### Secondary Outcomes

**Measure:** Percent of total lesion reduction at week 16 compared to baseline

**Time Frame:** Week 16

**Measure:** Percent of inflammatory lesion reduction at week 16 compared to baseline

**Time Frame:** Week 16

**Measure:** Percent of non-inflammatory lesion reduction at week 16 compared to baseline

**Time Frame:** Week 16

**Description:** The score in the scale ranges from 0-4. Lower score represents absence of erythema and higher score represents severe condition.

**Measure:** Tolerability measures of erythema based on 5-point severity scale

**Time Frame:** Week 52

**Description:** The score in the scale ranges from 0-4. Lower score represents absence of dryness and higher score represents severe condition.

**Measure:** Tolerability measures of dryness based on 5-point severity scale

**Time Frame:** Week 52

**Description:** The score in the scale ranges from 0-4. Score 0 represents absence of peeling and Score 4 represents 'Extensive peeling'.

**Measure:** Tolerability measures of peeling based on 5-point severity scale

**Time Frame:** Week 52

**Description:** The score in the scale ranges from 0-4. Score 0 represents absence of Oiliness and Score 4 represents severe condition.

**Measure:** Assessment of skin oiliness based on 5-point severity scale

**Time Frame:** Week 52

**Description:** The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition.

**Measure:** Tolerability measures of pruritus based on 6-point severity scale

**Time Frame:** Week 52

**Description:** The score in the scale ranges from 0-5. Lower score represents absence of discomfort and higher score represents severe condition.

**Measure:** Tolerability measures of burning/stinging based on 6-point severity scale

**Time Frame:** Week 52

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

i. Outpatient, male or female subjects of any race (Fitzpatrick skin types IV, V, VI), and at least 12 years of age or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study:

A female is considered of childbearing potential unless she is:

* postmenopausal for at least 12 months prior to study drug administration;
* without a uterus and/or both ovaries; or
* has been surgically sterile for at least 6 months prior to study drug administration.

Reliable methods of contraception are:

* hormonal methods or intrauterine device in use \> 90 days prior to study drug administration;
* barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
* vasectomized partner (vasectomy must be performed 3 months prior to first study drug administration or in the alternative a zero sperm count will suffice)

\[Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.\] ii. Facial acne IGA score of 3 or 4. iii. Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.

Exclusion Criteria:

i. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.

ii. Allergy or sensitivity to any component of the test medications (Section 5.2).

iii. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).

iv. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study.

v. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris vi. Evidence of recent alcohol or drug abuse. vii. History of poor cooperation, non-compliance with medical treatment, or unreliability.

viii. Exposure to an investigational drug study within 30 days of the Baseline Visit.

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Louisville

**Country:** United States

**Facility:** Skin Sciences, PLLC

**State:** Kentucky

**Zip:** 40217

## 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
