ACTRN12622000522718
Not yet recruiting
Phase 1
Comparison of the efficacy of two triple therapy topical combinations in the treatment of melasma in adults
Michelle Rodrigues0 sites20 target enrollmentApril 1, 2022
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Michelle Rodrigues
- Enrollment
- 20
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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