## Protocol Section
### Identification Module
**NCT ID:** NCT06425900

**Brief Title:** A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients

**Official Title:** Histologic and LCMS Evaluation of the Sebaceous Gland Changes Induced by Clascoterone Cream 1%

#### Organization Study ID Info
**ID:** DCS-115-22
#### Organization
**Class:** INDUSTRY
**Full Name:** Sun Pharmaceutical Industries Limited
### Status Module
#### Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-21
### 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:** to compare facial sebaceous gland morphology after 3 months of clascoterone cream 1% treatment and to compare facial sebum constituents at baseline to facial sebum constituents after 3 months of clascoterone cream 1% treatment

### 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) cream 1%

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

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Winlevi (Clascoterone ) cream 1%

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

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

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** The primary efficacy endpoint is the histologic demonstration of reduced facial sebaceous gland size when comparing baseline to 3 months of clascoterone cream 1 % treatment.

**Time Frame:** Week 12

#### Secondary Outcomes

**Measure:** The secondary efficacy endpoint is the changes in sebum composition when comparing baseline to 3 months of clascoterone cream 1 % treatment.

**Time Frame:** Week 12

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Female or male subjects age 18-35 years.
2. Subjects of all Fitzpatrick skin types.
3. Subjects with moderate facial acne and prominent pores indicating sebaceous gland activity.
4. Subjects with oily facial skin.
5. Subjects who agree to use only the study product and nothing else to the face.
6. Subject must possess no scars or tattoos or other confounding dermatologic conditions on the face in the preauricular biopsy sites on the left and right face.
7. Subjects agree not to introduce any new skin care products during the study.
8. No known medical conditions that, in the investigator's opinion, may interfere with study participation.
9. Subjects have signed an Informed Consent Form in compliance with 21CFR Part 50: "Protection of Human Subjects."
10. Subjects are dependable and able to follow directions and willing to comply with the schedule of visits.
11. Subjects 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.
2. Subjects who are not willing to use the assigned study product to their face as instructed.
3. Subjects who have used any topical prescription products on the face for 4 weeks prior to study entry.
4. Subjects who have used any OTC products on the face for 2 weeks.
5. Subjects with clinically significant unstable medical disorders.
6. Subjects who are unwilling or unable to comply with the requirements of the protocol.
7. 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.
8. Subjects currently participating in any other clinical trial.

**Maximum Age:** 25 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Clinical.Trial@sunpharma.com

**Name:** Head Clinical development

**Phone:** 9122 66455645

**Role:** CONTACT

#### 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
