Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facial Test Arm | Other |
| |
| Facial Control Arm | No Intervention | ||
| Arm Test arm | Other |
| |
| Arm control arm | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai China-norm Quality Technical Service Co., Ltd. | Shanghai | Shanghai Municipality | 200072 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004890 | Erythema |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C031149 | glycolic acid |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| D013568 | Pathological Conditions, Signs and Symptoms |