Inducing Redness Clinical Study

NCT ID: NCT07179263

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-22
• Study Completion Date: 2023-12-29

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) 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.

Conditions

Redness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Facial Test Arm

Group Type: OTHER

50% glycolic acid

Intervention Type: OTHER

Subjects use 3 drops about 0.2g of 50% Glycolic Acid product on half face under instruction, then wait for 3 minutes and wash face by tap water. Wait for 10 minutes before measuring.

Tape Stripping

Intervention Type: OTHER

Technician use the D100 to paste on the center of the test area and make it fit the skin more completely and evenly by pump fully cover the D100 patch for 10 seconds. Stripping on each test area until the skin change into redness. The number of stripping will be recorded.

Facial Control Arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Arm Test arm

Group Type: OTHER

Tape Stripping

Intervention Type: OTHER

Technician use the D100 to paste on the center of the test area and make it fit the skin more completely and evenly by pump fully cover the D100 patch for 10 seconds. Stripping on each test area until the skin change into redness. The number of stripping will be recorded.

Arm control arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

50% glycolic acid

Subjects use 3 drops about 0.2g of 50% Glycolic Acid product on half face under instruction, then wait for 3 minutes and wash face by tap water. Wait for 10 minutes before measuring.

Intervention Type: OTHER

Tape Stripping

Technician use the D100 to paste on the center of the test area and make it fit the skin more completely and evenly by pump fully cover the D100 patch for 10 seconds. Stripping on each test area until the skin change into redness. The number of stripping will be recorded.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

ChinaNorm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

C23036014

Identifier Type: -

Identifier Source: org_study_id