Inducing Redness Clinical Study

NCT07179263 | Completed

• 1 other identifier: C23036014
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Change in erythema index by Mexameter® MX 18 (

  From baseline to 4-hour after inducing

• Change in a* value by Chromameter CM26dG

  The a\*value is a parameter in the CIELAB color space (also known as Lab) that quantifies a color's position along the red-green axis .

  From baseline to 4-hour after inducing

• Facial Erythema Severity via VISIA-CRP Imaging

  From baseline to 4-hour after inducing

• Forearm Erythema Intensity via Cross-Polarized Light Imaging

  From baseline to 4-hour inducing

Study Arms (4)

Facial Test Arm

OTHER

Other: 50% glycolic acid; Other: Tape Stripping

Facial Control Arm

NO INTERVENTION

Arm Test arm

OTHER

Other: Tape Stripping

Arm control arm

NO INTERVENTION

Interventions

50% glycolic acid 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.

Facial Test Arm

Tape Stripping 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 Test arm; Facial Test Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• ChinaNorm: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200072, China

Location

MeSH Terms

Conditions

Erythema

Interventions

glycolic acid

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 17, 2025
• Study Start: December 22, 2023
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

CN (1)