Comparison of the efficacy of two triple therapy topical combinations in the treatment of melasma

Phase 1

• Conditions: Melasma; Skin - Dermatological conditions

• Registration Number: ACTRN12622000522718
• Lead Sponsor: Michelle Rodrigues

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-01
• Last Update Posted: 24 April 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Patient clinically diagnosed with melasma
- If patient is of childbearing age, she will be required to use a reliable contraceptive for at least 1 month and agree not to change her contraceptive status for the duration of the study
- Patient who has signed the written informed consent form for study participation

Exclusion Criteria

- Women who are pregnant or breast-feeding or who are planning for pregnancy during the course of the study. (A urine b-HCG or urine dipstick test will be performed)
- Patient with another pigmentation disorder on the face.
- Patient with other dermatoses that may interfere with the evaluation or application of the products involved in the study.
- Patient who has used a depigmentation agent in the month prior to inclusion.
- Patient who has used a local corticosteroid on the skin, eyes, nose or mouth (inhaled corticosteroid) or systemic corticosteroids during the month prior to inclusion.
- Patient who has used local tretinoin or hydroquinone in the month prior to inclusion.
- Patient on chronic anti-inflammatory therapies (patient accepted into study if cumulative NSAID use is less than 10 days over the duration of the study).
- Patient with a clinically significant history of allergy, especially to the components of the products studied.
- Vulnerable persons including people under the age of 18 and those who are unable to take care of or protect themselves against harm or exploitation.
- Patient being in a situation that, in the investigator's opinion, may interfere with optimal participation in the study.
- Patient who is participating or has participated in another clinical drug trial in the month prior to inclusion.
- Patient who cannot communicate effectively with the investigator or who cannot follow the instructions involved in the study.
- Patient who is refusing to be photographed as part of the study.
- Patient who withdraws their informed consent from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified