Status:
COMPLETED
Inducing Redness Clinical Study
Lead Sponsor:
ChinaNorm
Conditions:
Redness
Eligibility:
FEMALE
18-60 years
Phase:
NA
Brief Summary
This clinical study employs a single-center, split-face, randomized, and on-site controlled design to compare two methods for inducing skin redness (50% Glycolic Acid application and tape stripping) o...
Eligibility Criteria
Inclusion
- Chinese female whose age range from 18 to 60 years old;
- Be in general good health and good mental state;
- Have no any broken, scars, birthmarks and other imperfections on the test area;
- Redness/erythema ≥ grade 2 after modelling inducing (to ensure the consistency of the baseline for comparison);
- Haven't applied Alpha hydroxyl acid in the past 3 months;
- Not currently be participating in any other study involving the test area (Face and Forearm);
- Not have participated in any other study involving the test area in the past one month;
- Be willing to read, understand and able to sign the Informed Consent Form and Photo Release From;
- Be willing to comply with all study protocol requirements.
Exclusion
- Intending to get pregnant, be pregnant, be lactating, be within 6 months of delivery or be unwilling to take necessary precautions to avoid a pregnancy;
- Having used antihistamine drugs in the past 1 week or immunosuppressants in the past 1 month;
- Take anti-allergic drug/injections in the past 1 month;
- Presently have allergies, allergic dermatitis or skin disease;
- Have sensitivity or even allergy to topical products, ingredients or fragranced products;
- Have history of allergies;
- Have history of suffering from skin diseases (such as psoriasis, eczema, psoriasis, skin cancer, etc.);
- Have used any anti-inflammatory treatment on the test area within 2 months prior to this study starting date;
- Has a chronic medical condition that may interfere with testing (e.g., asthma, insulin-dependent diabetes, lupus, rheumatoid arthritis or other immune/auto-immune diseases);
- Have used any scrubs or peeling product (regardless of method) or self-tanning products or oil control products in the past 3 days;
- Have received cosmetic medical procedures on the face (such as injectable anti-wrinkle products, cosmetic surgery, tattoo removal, home light facial procedures or home use medical devices, etc.) in the past 1 month;
- Have excessive sun exposure or ultraviolet light in the past 1 month;
- Have applied ortho-hydroxybenzoic acid, hydroquinone in the past 3 months; or used prescriptions (such as antibiotic, retinoids, alpha hydroxyl acid and steroid), oral contraceptives (such as Diane 35®，Jasmine®， Holgyeme®，Syndi 35®，Regulon®);
- Avoid providing emergency contact;
- Subjects that are not compliant to the selection criteria or not proper for participation as determined by Principal Investigator;
- An employee of the cosmetic companies or Shanghai China-Norm Quality technical service Co., Ltd.
Key Trial Info
Start Date :
December 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2023
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT07179263
Start Date
December 22 2023
End Date
December 29 2023
Last Update
September 17 2025
Active Locations (1)
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1
Shanghai China-norm Quality Technical Service Co., Ltd.
Shanghai, Shanghai Municipality, China, 200072