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Clinical evaluation of cosmetic ingredients for whitening and freckle-removing efficacy using a UV-induced pigmentation model

Randomised, double-blind, controlled clinical trial to evaluate the efficacy of 17 common whitening cosmetic ingredients at their maximum permitted concentrations

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11405020
Enrollment
33
Registered
2025-10-30
Start date
2025-11-01
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperpigmentation, skin whitening efficacy Skin and Connective Tissue Diseases

Interventions

Intervention type: Topical application of cosmetic whitening emulsions Intervention details: 17 whitening cosmetic emulsions tested: Kojic acid (0.7%), Arbutin (2%), Niacinamide (3%), Vitamin C (7%),

Sponsors

Shenzhen Hujia Technology Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime 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

MeasureTime 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

Contacts

Public ContactGuoying Li
caohejingschc@163.com+86 17321318135

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026