Efficacy of Eflornithine Hydrochloride Cream in the Treatment of Melasma: A Randomized, Double-blinded, Split-face Controlled Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2024-07-11

Brief Summary

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The goal of this clinical trial is to learn if Eflornithine hydrochloride cream works to treat melasma in adults, in comparison to Hydroquinone cream. It will also learn about the safety of Eflornithine hydrochloride cream. The main questions it aims to answer are:

* Does Eflornithine hydrochloride improve melasma assessment scores over a 3-month duration compared to Hydroquinone cream?
* What side effects might patients get while using Eflornithine hydrochloride cream?

Participants will:

* Apply both Eflornithine hydrochloride and Hydroquinone creams on separate halves of their faces every day for 3 months.
* Visit the clinic once at the 2-month mark and once at the 3-month mark for checkups and tests.

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Detailed Description

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Conditions

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Melasma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a randomized, double-blinded, split-face study. Both treatments (Eflornithine hydrochloride, and Hydroquinone) will be applied simultaneously: one on the left side of the face and the other on the right side. Treatment allocation to facial sides will be randomized, and participants blinded (both treatments with similar packaging, look and consistency). Outcomes will be assessed on each side of the face by a blinded evaluator.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face

Group Type ACTIVE_COMPARATOR

Eflornithine hydrochloride cream

Intervention Type DRUG

Eflornithine hydrochloride cream at 11.5% applied twice daily

Hydroquinone cream

Intervention Type DRUG

Hydroquinone 2% cream, applied twice daily

Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face

Group Type ACTIVE_COMPARATOR

Eflornithine hydrochloride cream

Intervention Type DRUG

Eflornithine hydrochloride cream at 11.5% applied twice daily

Hydroquinone cream

Intervention Type DRUG

Hydroquinone 2% cream, applied twice daily

Interventions

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Eflornithine hydrochloride cream

Eflornithine hydrochloride cream at 11.5% applied twice daily

Intervention Type DRUG

Hydroquinone cream

Hydroquinone 2% cream, applied twice daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of melasma
* Fitzpatrick Type III or IV
* Able to provide informed consent

Exclusion Criteria

* Pregnant or lactating patients
* Patients with difficulty adhering to regular topical treatments
* Patients with known contact allergies to any of the ingredients in the topical medications used in the study

Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No