Clinical trial NCT06985745: Emulsion 8-Week Anti-acne Efficacy Clinical Study
Official title: An Emulsion 2-Week Wash-out, 4-Week Application and Relapse for 2-Week Anti-acne Efficacy Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Female
Male
Acne
Lead sponsor: ChinaNorm
Sponsor class: INDUSTRY
First posted: 2025-05-22
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Clinical scoring for Counting of Acne
timeFrame: Timepoint 2Week before baseline，Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
measure: Clinical scoring for Redness around acne
timeFrame: Baseline，Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
measure: Clinical scoring for Diameter of tracking one Acne
timeFrame: Baseline，Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week.
measure: Clinical scoring for Cheek Sebaceous Pores
timeFrame: Timepoint 2Week before baseline, Baseline，Time point immediate, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
measure: Skin hydration on the cheeks
timeFrame: Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
measure: TEWL on the cheeks
timeFrame: Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
measure: Sebum secretion on forehead
timeFrame: Baseline, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
measure: Image capture and analysis（facial photo）
timeFrame: Baseline, Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week , Time point at 4Week, Time point at 5Week, Time point at 6Week.
measure: One tracking active acne image
timeFrame: Baseline，Time point immediate, Time point at 1Day, Time point at 3Day, Time point at 1Week.
measure: Image Capture and Analysis(RCM)
timeFrame: Baseline, Time point 4Week.
measure: Image Capture using VisioScan® VC20plus
timeFrame: Baseline, Time point 4Week.
Secondary outcomes:
measure: Consumer Questionnaire
timeFrame: Time point immediate, Time point at 1Week , Time point at 4Week.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai China-norm Quality Technical Service Co., Ltd.
state: Shanghai
Study officials:
affiliation: Shanghai China-norm Quality Technical Service Co., Ltd.
name: Ping Xu, Master
role: PRINCIPAL_INVESTIGATOR
References: