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

N

National Skin Centre

Status and phase

Completed
Phase 2

Conditions

Melasma

Treatments

Drug: Hydroquinone cream
Drug: Eflornithine hydrochloride cream

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT06957834
2019/00399

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

25 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

20 participants in 2 patient groups

Eflornithine hydrochloride cream on right half of face, Hydroquinone cream on left half of face
Active Comparator group
Treatment:
Drug: Eflornithine hydrochloride cream
Drug: Hydroquinone cream
Eflornithine hydrochloride cream on left half of face, Hydroquinone cream on right half of face
Active Comparator group
Treatment:
Drug: Eflornithine hydrochloride cream
Drug: Hydroquinone cream

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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