Not Yet RecruitingPhase 1ACTRN12622000522718

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

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

Sponsor

Michelle Rodrigues

Enrollment

20 participants

Start Date

Aug 1, 2023

Study Type

Interventional

Conditions

Melasma

Summary

Melasma is a common disorder of hyperpigmentation, primarily affecting the face. It can affect all racial types but predominately affects women with darker skin types. The exact cause of melasma is unknown, but it is thought to be due to many things including pregnancy, hormonal contraception, and sunlight. Melasma can be very difficult to treat and often frustrating for the patient and doctor with evidence showing that it may adversely affect quality of life. The standard topical treatment for melasma that has been used since the 1970’s, is a combination agent including hydroquinone 5%, retinoic acid 0.1% and dexamethasone acetate 0.1% (commonly called “Kligman’s Trio”). Although this treatment is effective, it frequently causes skin irritation, and the hydroquinone is largely responsible for this. Hydroquinone also carries a risk of causing skin discolouration with long-term use. Thiamidol, like hydroquinone, is a depigmentation agent. Recent studies showed that thiamidol was better than hydroquinone in treating melasma while causing fewer side effects (Arrowitz et al, Journal of Investigative Dermatology, 2019). Replacing hydroquinone with thiamidol in this readily prescribed depigmentation formula has never been studied. Therefore, this study aims to determine if topical thiamidol + retinoic acid + dexamethasone acetate combination treats melasma as well as the standard Kligman's Trio.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

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 Criteria14

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.

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Interventions

Combination topical therapy of: 1. Thiamidol 100g 2. Retinoic acid 0.05%, 0.1g 3. Dexamethasone acetate 0.1%, 0.1g Patients will be instructed to apply a pea-sized (approximately 2mL) amount of th

Combination topical therapy of: 1. Thiamidol 100g 2. Retinoic acid 0.05%, 0.1g 3. Dexamethasone acetate 0.1%, 0.1g Patients will be instructed to apply a pea-sized (approximately 2mL) amount of the combination product across their entire face every night for 12 consecutive weeks. Patients will also be instructed to apply a teaspoon amount of SPF 50 sunscreen 3 times a day for the same treatment period as well as 12 weeks after cessation of the combination therapy while the skin is expected to remain photosensitive due to the residual effects of treatment. Medication adherence will be evaluated at the end of the 12-week treatment period by assessing the amount of remaining product.