Status:
ACTIVE_NOT_RECRUITING
Emulsion 8-Week Anti-acne Efficacy Clinical Study
Lead Sponsor:
ChinaNorm
Conditions:
Female
Male
Eligibility:
All Genders
20-40 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Chinese man and women aged from 20-40 years old.
- Acne prone skin with combination to oil and oil skin type.
- At least 50% self-declared sensitive skin.
- 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.
- Presenting with Cheek Sebaceous Pores (Skin aging ATLAS Vol.2 Asian Type) ≥ 3 score (0-5 scale)
- At least 1 active inflammatory lesion can be tracked.
- Subjects with acne red mark (PIE)
- 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.
- 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.
- Must be willing to comply with all study protocol requirements
Exclusion
- Pregnant or breast-feeding woman or woman planning pregnancy during the study. (applicable only to female)
- With facial hair that may interfere with the assessment or image captured of the test area (applicable only to males);
- 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.)
- Subject with a skin disease in the test areas (particularly e.g, acne, rosacea, eczema).
- Subjects with history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, medication, cosmetic or personal care products or ingredients.
- Subject presenting a stable or progressive serious disease (per investigator's assessment).
- Immuno-compromised subject.
- Subject presenting excessive exposure to sunlight or UV radiation (investigator's assessment).
- Subjects regularly practicing aquatic or nautical sports.
- Subjects regularly attending a sauna.
- Subject with cardiovascular or circulatory history.
- Subject with a history of skin cancer or malignant melanoma.
- Anti-aging medical beauty project or anti-aging cosmetics clinical research in the last 6 months before study.
- Participants who took oral isotretinoin capsules within the 6 months prior to the testing period.
- Intake of antihistamines, antibiotics, corticosteroids, non-steroidal anti-inflammatories or immune-suppressants in the last 6 months before study.
- Participants who are currently or have participated in other clinical trials within the past month.
Key Trial Info
Start Date :
March 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06985745
Start Date
March 8 2025
End Date
May 27 2025
Last Update
May 30 2025
Active Locations (1)
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1
Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, China, 200072