Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma (NCT06516224) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma
Brazil150 participantsStarted 2024-07-15
Plain-language 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) followed by the dermocosmetic regimen for 3 months or the Kligman Trio for 3 months followed by the dermocosmetic regimen for 3 months in adult women with melasma on the face.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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.