Hyperpigmentation, skin whitening efficacy Skin and Connective Tissue Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy male or female participants aged 18 to 60 years 2. Skin ITA° value between 20° and 41° 3. No history of allergic reactions to cosmetics or other topical products 4. No history of photosensitivity disorders or related conditions 5. No pigmentation, scars, or moles at the test site on the back 6. Able to understand the study protocol and provide written informed 7consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women, or those planning pregnancy 2. History of skin diseases such as psoriasis, eczema, atopic dermatitis, or severe acne 3. Recent use (within 1 month) of corticosteroids or skin-lightening products (e.g., hydroquinone) 4. Participation in another clinical trial within the last 2 months 5. Family history of skin cancer or immunosuppression (e.g., HIV positive, organ transplant recipients) 6. Recent (within 8 weeks) exposure to tanning or excessive sun exposure 7. Participants with a history of allergic reactions to cosmetics or other topical products 8. Participants with pigmentation, inflammation, scars, or moles at the test site 9. Inability to comply with study procedures or unwillingness to sign informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. ITA° value (skin color measurement by spectrophotometer) at Day 8 (baseline after pigmentation), Day 15, Day 22, Day 29, and Day 36 2. MI (melanin index measured by Mexameter probe) at Day 8 (baseline after pigmentation), Day 15, Day 22, Day 29, and Day 36 3. Visual skin color assessment (by dermatologist) at Day 8 (baseline after pigmentation), Day 15, Day 22, Day 29, and Day 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Monitoring and reporting of adverse events such as redness, itching, irritation, or allergic reactions related to the intervention measured using patient records throughout with a summary at Day 36 | — |
Countries
China