Emulsion 8-Week Anti-acne Efficacy Clinical Study

NCT ID: NCT06985745

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-08
• Study Completion Date: 2025-05-27

Brief Summary

65 male and female adult subjects will be enrolled in the study, recruited according to inclusion and non-inclusion criteria listed below, at least 60 subjects should complete questionnaire, at least 40 of them should complete clinical assessment, instrumental measurement and image capture. 20 of them should complete lipid sample collection, and at least 30 of them should complete the RCM captured.

Conditions

Female; Male; Acne

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group Emulsion

Group Type: OTHER

Standard Cleanser, Investigational emulsion, Standard moisturizer, Standard Sunscreen

Intervention Type: OTHER

Products Application and Usage Instruction:

Wash out: T-2W ~ T0

Frequency:

AM: Standard cleanser + standard moisturizer + standard sunscreen PM: Standard cleanser + standard moisturizer Caution: All the products should be applied to full face. No any other skincare or facial make up products are used except provide products.

b. Mode of application : 4-week Treatment T0 ~ T4W

Frequency:

AM: Standard cleanser + test emulsion (FLA#2039180 68) + standard sunscreen PM: Standard cleanser + test emulsion (FLA#2039180 68) Caution: All the products should be applied to full face. No other skincare or facial make up products are used except provide products.

c. Mode of application : 2-week relapse T4W ~ T6W AM: Standard cleanser + standard moisturizer + standard sunscreen PM: Standard cleanser + standard moisturizer

Usage Instruction： Test emulsion (FLA#2039180 68): Self-application 0.6 ml for full face by hand every day (2x/day).

Interventions

Standard Cleanser, Investigational emulsion, Standard moisturizer, Standard Sunscreen

Products Application and Usage Instruction:

Wash out: T-2W ~ T0

Frequency:

AM: Standard cleanser + standard moisturizer + standard sunscreen PM: Standard cleanser + standard moisturizer Caution: All the products should be applied to full face. No any other skincare or facial make up products are used except provide products.

b. Mode of application : 4-week Treatment T0 ~ T4W

Frequency:

AM: Standard cleanser + test emulsion (FLA#2039180 68) + standard sunscreen PM: Standard cleanser + test emulsion (FLA#2039180 68) Caution: All the products should be applied to full face. No other skincare or facial make up products are used except provide products.

c. Mode of application : 2-week relapse T4W ~ T6W AM: Standard cleanser + standard moisturizer + standard sunscreen PM: Standard cleanser + standard moisturizer

Usage Instruction： Test emulsion (FLA#2039180 68): Self-application 0.6 ml for full face by hand every day (2x/day).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Chinese man and women aged from 20-40 years old.

2. Acne prone skin with combination to oil and oil skin type.

3. At least 50% self-declared sensitive skin.

4. Presenting with mild to moderate IGA (Acne Severity 0-4 scale, 2-3 score). 1) At least 5 inflammatory acne lesions (papules, pustules) on the global face. 2) At least 10 non-inflammatory acne lesions (blackhead, whitehead) on the global face.

5. Presenting with Cheek Sebaceous Pores (Skin aging ATLAS Vol.2 Asian Type) ≥ 3 score (0-5 scale)

6. At least 1 active inflammatory lesion can be tracked.

7. Subjects with acne red mark (PIE)

8. Presenting with skin lack of smoothness, radiance, brightness, softness evaluated by dermatologist and have skin redness concerns.

1) Skin smoothness (0-9 scale, 3≤ grade≤ 6) 2) Skin radiance (0-9 scale, 3≤ grade≤ 6) 3) Skin brightness (0-9 scale, 3≤ grade≤ 6) 4) Skin softness (0-9 scale, 3≤ grade≤ 6) 5) Skin redness (0-9 scale, 3≤ grade≤ 6) 9.No disagreement of dermatologist because of other reasons that exclude the participation of the subject.

10.In general good health at the time of the study. 11.Willing and able to participate as evidenced by signing of informed consent and photo release form.

12.Must be willing to comply with all study protocol requirements

Exclusion Criteria

1. Pregnant or breast-feeding woman or woman planning pregnancy during the study. (applicable only to female)

2. With facial hair that may interfere with the assessment or image captured of the test area (applicable only to males);

3. Unable to participate in the trial according to the study schedule or other situations that are unsuitable for participation (e.g. Subject deprived of rights by a court or administrative order. Major subject to a guardianship order. Subject residing in a health or social care establishment. Patient in an emergency setting.)

4. Subject with a skin disease in the test areas (particularly e.g, acne, rosacea, eczema).

5. Subjects with history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, medication, cosmetic or personal care products or ingredients.

6. Subject presenting a stable or progressive serious disease (per investigator's assessment).

7. Immuno-compromised subject.

8. Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).

9. Subjects regularly practicing aquatic or nautical sports.

10. Subjects regularly attending a sauna.

11. Subject with cardiovascular or circulatory history.

12. Subject with a history of skin cancer or malignant melanoma.

13. Anti-aging medical beauty project or anti-aging cosmetics clinical research in the last 6 months before study.

14. Participants who took oral isotretinoin capsules within the 6 months prior to the testing period.

15. Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study.

16. Participants who are currently or have participated in other clinical trials within the past month.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ChinaNorm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ping Xu, Master

Role: PRINCIPAL_INVESTIGATOR

Shanghai China-norm Quality Technical Service Co., Ltd.

Locations

Shanghai China-norm Quality Technical Service Co., Ltd.

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

C25005028

Identifier Type: -

Identifier Source: org_study_id