Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma

Launched by COSMETIQUE ACTIVE INTERNATIONAL · Jul 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective a specific skincare routine is for treating melasma, a condition that causes dark patches on the skin, especially on the face. The trial will compare the effects of a combination of a serum and a night cream (called Serum B3 and B3 retinol night cream) used for six months against two established treatments: hydroquinone (a well-known treatment for skin discoloration) and the Kligman Trio (a combination of creams) used for three months, followed by the new skincare routine for another three months.

To participate, women aged 18 to 65 with certain skin types and well-defined melasma that has been present for over a year may be eligible. However, those who have recently used certain medications or treatments for melasma or have specific health conditions won't be able to join. Participants in the trial can expect to use the provided skincare products and attend regular check-ins to monitor their skin's progress. It's important to know that the trial is not yet recruiting participants, so there will be a wait before it begins.

Gender

FEMALE

Eligibility criteria

• 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.