Comparison of Efficacy of Topical Westerhoff Formula Cream Vs Topical 4% Hydroquinone for the Treatment of Melasma

March 27, 2026 updated by: Dr Syed Muzzamal Bukhari, Pak Emirates Military Hospital
study was conducted on middle aged male and female, including families and health care professional also.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

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

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 46000
        • Dermatology Department of Tertiary Care Hospital

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patient with facial melasma of age between 15 years to 45 years of both gender

Exclusion Criteria:

  • patient who have already taken treatment within 8 weeks, pregnant women, who are taking hormonals therapy and patient of dementia

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (Triple combination group)
participants in this arm will receive topical westerhoff formula cream which is combination of 4.7% of N-acetylcysteine, 2% hydroquinone and 0.1% Triamcinolone acetate twice daily for 8 weeks for the treatment of facial melasma
Drug: Triple combination cream
4.7% N-acetylcysteine, 2% Hydroquinone and 0.1 % triamcinolone acetate twice daily for 8 weeks
Active Comparator: Arm 2 (4 % Hydroquinone)
participant in this group will receive 4% hydroquinone twice daily for 8 weeks for the facial melasma.
Drug: Hydroquinone 4% Cream
twice daily for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of participants achieving 60% reduction in the melasma area severity index (MASI-60)
Time Frame: 8 weeks
the primary outcome is the proportion of the participants achieving 60% reduction in MASI score from baseline after 8 weeks of treatment. MASI is the scoring system used to assess the melasma on the basis of severity darkness and the homogeneityenicity
8 weeks
proportion of participants achieving >60% reduction in Melasma Area and severity index (MASI-60)
Time Frame: baseline to 8 weeks
The primary outcome is the proportion of the participants achieving 60% reduction in MASI Score rom the baseline after treatment. MASI is the scoring system used to assess the severity of melasma based on the area, darkness nd the homogeneity
baseline to 8 weeks

Collaborators and Investigators

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

Sponsor

Pak Emirates Military Hospital

Investigators

  • Study Director: QAMMAR khan DR, MBBS. FCPS(Dermatalogy), Pak Emirates Military Hospital
  • Study Chair: Moizza tHAIR Dr, MBBS.FCPS(Dermatology), Pak Emirates Military Hospital

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)

July 18, 2025

Primary Completion (Actual)

January 19, 2026

Study Completion (Actual)

January 19, 2026

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 2, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PakEmiratesMH.westerhoff
  • PEMH hospital rawalpindi (Other Identifier: PEMH rawalpindi)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identify patient data, MASI and treatment allocation

IPD Sharing Time Frame

DATA WILL BE AVAILABLE AFTER PUBLICATION FOR A PEROID OF ONE YEAR

IPD Sharing Access Criteria

ACCESS TO THE CLINICAL STUDY REPORT WILL BE PROVIDED TO QUALIFIED RESEARCHER UPON REASONABLE REQUEST TO A PRICIPLE INVESTIGATO

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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