EFFICACY and TOLERABILITY of TESTED FORMULA VS. HYDROQUINONE 4% in the TREATMENT of FACIAL MELASMA

Launched by COSMETIQUE ACTIVE INTERNATIONAL · Jan 16, 2025

Keywords

ClinConnect Summary

Topical treatments are usually used first line. Among a high number of molecules claiming a depigmenting effect, hydroquinone used at various concentrations (typically 2 to 5%) is the most widely used skin depigmenting product and is considered, up to now, the gold standard when used at 4-5%.

Hydroquinone is sometimes combined in the Kligman's trio, with topical tretinoin and topical steroids, which remains the best initial treatment for melasma in terms of efficacy.

This randomized , two-arm study is carried out with a new cosmetic formulation developed with the aim of acting on facial h...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Women;
• • 2. Adults (over 18 y.o.) (preference 18-50 y.o.);
• • 3. Phototypes I to IV;
• • 4. Melasma epidermal or mixed (exclude dermal melasma);
• • 5. Ready to protect as much as possible from the sun for the duration of the study;
• • 6. Ready to avoid contraindicated products (irritants, other depigmenting agents);
• • 7. Participants demonstrating understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the informed consent form.
• • Exclusion criteria
• • 1. Subjects with dermal melasma (wood lamp at inclusion);
• • 2. Subjects who has already use of hydroquinone 4% in the past year;
• • 3. Subjects with stable hormonal therapy (contraceptive ou THS) for at least 6 months;
• • 4. Pregnant or breastfeeding women or pregnancy plans;
• • 5. Subjects applying irritants (such as peeling, acid..) (2 weeks wash out);
• • 6. Subjects under active treatment of melasma (including topicals or procedures) within the last 2 weeks;
• • 7. Subjects using drugs that can induce melasma such as antiepileptics (1 month wash out);
• • 8. Subjects using other products claiming a depigmenting activity (1 month wash out);
• • 9. Subjects with other dermatosis of the face or known photosensitivity;
• • 10. All types of topical treatment applied to the face (wash out of 2 weeks)
• • 11. Subjects without any facial procedure planned during the course of the study
• • 12. Subjects under phototherapy (1 month wash out)
• • 13. Subjects hypersensitivity to the products of the study
• • 14. Any history of significant dermatological/ophthalmological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction
• • 15. 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.
• • 16. Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics, or medication
• • 17. Participation in another clinical study
• • 18. Employee of the sponsor or the study site