Inducing Redness Clinical Study

ChinaNorm

Status: Completed

Conditions: Redness

Treatments: Other: Tape Stripping; Other: 50% glycolic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT07179263

C23036014

Details and patient eligibility

About

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) on the face and forearm in a minimum of 40 healthy female subjects. The study involves instrumental measurements (erythema index and a* value), photographic analysis, and expert clinical grading at multiple time points (baseline, 10min, 30min, 1h, 2h, and 4h after induction) to evaluate and compare the efficacy and response profiles of both irritation models.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Chinese female whose age range from 18 to 60 years old;
2. Be in general good health and good mental state;
3. Have no any broken, scars, birthmarks and other imperfections on the test area;
4. Redness/erythema ≥ grade 2 after modelling inducing (to ensure the consistency of the baseline for comparison);
5. Haven't applied Alpha hydroxyl acid in the past 3 months;
6. Not currently be participating in any other study involving the test area (Face and Forearm);
7. Not have participated in any other study involving the test area in the past one month;
8. Be willing to read, understand and able to sign the Informed Consent Form and Photo Release From;
9. Be willing to comply with all study protocol requirements.

Exclusion criteria

1. 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;
2. Having used antihistamine drugs in the past 1 week or immunosuppressants in the past 1 month;
3. Take anti-allergic drug/injections in the past 1 month;
4. Presently have allergies, allergic dermatitis or skin disease;
5. Have sensitivity or even allergy to topical products, ingredients or fragranced products;
6. Have history of allergies;
7. Have history of suffering from skin diseases (such as psoriasis, eczema, psoriasis, skin cancer, etc.);
8. Have used any anti-inflammatory treatment on the test area within 2 months prior to this study starting date;
9. 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);
10. Have used any scrubs or peeling product (regardless of method) or self-tanning products or oil control products in the past 3 days;
11. 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;
12. Have excessive sun exposure or ultraviolet light in the past 1 month;
13. 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®);
14. Avoid providing emergency contact;
15. Subjects that are not compliant to the selection criteria or not proper for participation as determined by Principal Investigator;
16. An employee of the cosmetic companies or Shanghai China-Norm Quality technical service Co., Ltd.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 4 patient groups

Facial Test Arm

Other group

Treatment:

Other: 50% glycolic acid

Other: Tape Stripping

Facial Control Arm

No Intervention group

Arm Test arm

Other group

Treatment:

Other: Tape Stripping

Arm control arm

No Intervention group