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

NCT07508098 | Completed Phase 4 DMC FDA Drug

• 2 other identifiers: PakEmiratesMH.westerhoffPEMH hospital rawalpindi
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

study was conducted on middle aged male and female, including families and health care professional also.

Conditions

Melasma (Facial Melasma)

Keywords

MASI. Melasma. Westerhoff formula. 4 % Hydroquinone

Outcome Measures

Primary Outcomes (2)

• proportion of participants achieving 60% reduction in the melasma area severity index (MASI-60)

  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)

  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

Study Arms (2)

Arm 1 (Triple combination group)

EXPERIMENTAL

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

Arm 2 (4 % Hydroquinone)

ACTIVE COMPARATOR

participant in this group will receive 4% hydroquinone twice daily for 8 weeks for the facial melasma.

Drug: Hydroquinone 4% Cream

Interventions

Triple combination cream DRUG

4.7% N-acetylcysteine, 2% Hydroquinone and 0.1 % triamcinolone acetate twice daily for 8 weeks

Arm 1 (Triple combination group)

Hydroquinone 4% Cream DRUG

twice daily for 8 weeks

Arm 2 (4 % Hydroquinone)

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: Female gender of reproductive age
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pak Emirates Military Hospital: lead

Study Sites (1)

Dermatology Department of Tertiary Care Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Melanosis

Interventions

hydroquinone

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• QAMMAR khan DR, MBBS. FCPS(Dermatalogy)

  Pak Emirates Military Hospital

  STUDY DIRECTOR

• Moizza tHAIR Dr, MBBS.FCPS(Dermatology)

  Pak Emirates Military Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registrar Dermatology

Model Details: participants will be assigned to two parallel groups receiving either triple combination therapy or 4% hydroquinone cream and outcome will be compared between groups

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: July 18, 2025
• Primary Completion: January 19, 2026
• Study Completion: January 19, 2026
• Last Updated: April 2, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: DATA WILL BE AVAILABLE AFTER PUBLICATION FOR A PEROID OF ONE YEAR
• Access Criteria: ACCESS TO THE CLINICAL STUDY REPORT WILL BE PROVIDED TO QUALIFIED RESEARCHER UPON REASONABLE REQUEST TO A PRICIPLE INVESTIGATO

Locations

PA (1)