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

May 2, 2025 updated by: Steven Thng Tien Guan, National Skin Centre

Randomised Double-blinded Split-face Controlled Study to Evaluate the Effectiveness of Eflornithine Hydrochloride Cream Compared to Topical Hydroquinone 2% Cream for the Treatment of Melasma.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • National Skin Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face
Drug: Eflornithine hydrochloride cream
Eflornithine hydrochloride cream at 11.5% applied twice daily
Drug: Hydroquinone cream
Hydroquinone 2% cream, applied twice daily
Active Comparator: Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face
Drug: Eflornithine hydrochloride cream
Eflornithine hydrochloride cream at 11.5% applied twice daily
Drug: Hydroquinone cream
Hydroquinone 2% cream, applied twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Melasma Area and Severity Index (mMASI)
Time Frame: At 8 weeks and 12 weeks
At 8 weeks and 12 weeks
Mexameter melanin score
Time Frame: At 8 and 12 weeks
Mexameter device (Courage + Khazaka Electronic GmbH, Germany)
At 8 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mexameter erythema score
Time Frame: At 8 and 12 weeks
Mexameter device (Courage + Khazaka Electronic GmbH, Germany)
At 8 and 12 weeks
Patient Satisfaction Score
Time Frame: At 8 and 12 weeks
For each side of the face, each patient and dermatologist was asked to grade the severity of melasma from a score of 0 (cleared), 1 (mild), 2 (moderate) to 3 (severe)
At 8 and 12 weeks
Physician Global Assessment
Time Frame: At 8 and 12 weeks
For each side of the face, each patient and dermatologist was asked to grade the severity of melasma from a score of 0 (cleared), 1 (mild), 2 (moderate) to 3 (severe)
At 8 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Skin Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2023

Primary Completion (Actual)

July 11, 2024

Study Completion (Actual)

July 11, 2024

Study Registration Dates

First Submitted

May 2, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 5, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/00399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in publication

IPD Sharing Time Frame

Beginning 6 months and ending 2 years after publication

IPD Sharing Access Criteria

Upon reasonable request to corresponding author

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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