Status:
NOT_YET_RECRUITING
Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma
Lead Sponsor:
Cosmetique Active International
Conditions:
Melasma
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
This 6 month, comparative study assesses the benefit of a dermocosmetic regimen (Serum B3 + B3 retinol night cream) for 6 months compared to hydroquinone 4% (the gold standard in hyperpigmentation) fo...
Detailed Description
Study objective 1. Assessing the antipigmenting efficacy of the routine (serum B3 + B3 retinol night cream) in women with melasma. 2. Evaluation of Kligman Trio (KT) (Vitacid Plus) compared to the ro...
Eligibility Criteria
Inclusion
- 18-65 years
- Phototype II-V
- 50% with sensitive skin (declarative);
- Subjects should be affected by well defined symmetrical (on both sides of the face) epidermal melasma (clinically diagnosed under Wood's light examination) lasting since more than a year
Exclusion
- Subjects under topical or systemic retinoids;
- Subjects having used topical tretinoin within 3 months or topical hydroquinone within 6 months prior to inclusion;
- Subjects under systemic immunosuppressants and considered immune compromised
- Subjects under active treatment of melasma (including topicals or procedures) within the last 3 months
- Pregnant women and/or breastfeeding women
- Subjects with a recent change in contraception (since less than 6 months);
- Subjects known allergy to any component of tested product;
- Subjects not presenting with the conditions needed to comply with the protocol;
- Subjects without any other dermatological conditions on the face
- Subject under menopause phase with hormonal replace therapy
- Subjects in the initial phase, change or discontinuation of hormonal treatment (estroprogesterone, cyproteron acetate, androgenic...) in the last 3 months;
- Subjects currently using any medication, which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
- Subjects unable to give their informed consent.
Key Trial Info
Start Date :
July 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06516224
Start Date
July 15 2024
End Date
January 31 2025
Last Update
July 23 2024
Active Locations (1)
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1
CIDP
Rio de Janeiro, Brazil