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Completed

NCT Number: NCT06957834

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

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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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Skin Centre

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eflornithine hydrochloride cream

Drug

Eflornithine hydrochloride cream at 11.5% applied twice daily

Hydroquinone cream

Drug

Hydroquinone 2% cream, applied twice daily

Primary outcomes

  1. Modified Melasma Area and Severity Index (mMASI)

    Time frame: At 8 weeks and 12 weeks

  2. Mexameter melanin score

    Time frame: At 8 and 12 weeks

    Mexameter device (Courage + Khazaka Electronic GmbH, Germany)

Secondary outcomes

  1. Mexameter erythema score

    Time frame: At 8 and 12 weeks

    Mexameter device (Courage + Khazaka Electronic GmbH, Germany)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

National Skin Centre

Network

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 5, 2025
Registry last updated
May 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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