MedTrace Logo

Efficacy of New Trio Combination for Melasma

NCT07676994 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-06-30

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if the drug New Trio Combination (0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone) works to treat melasma. It will also learn about the safety of drug. This drug lowers the pigmentation severity by measuring modified Melasma Area and Severity Index (mMASI) reduction by up to 50%. The possible side effects of this drug are erythema and burning. We will compare this drug to kligman's formula (5% hydroquinon, 0.1% retinoic acid and 0.1% dexamethasone) to see if New Trio Combination works to treat melasma patients. All subjects will be divided in two groups. Group 1 will receive New trio combination (NT) and group 2 will receive Kligman's formula (KG), once daily (night time application) for 3 months. Patients will be called for follow up at 4, 8 and 12 weeks.

A total of 56 patients fulfilling the inclusion criteria are enrolled in the study. Efficacy of New Trio Combination versus Kligman's Formula will be measured in all selected patients suffering from melasma by estimating improvement in the modified MASI score and MELASQoL at each follow up.

Conditions

  • Melasma

Interventions

DRUG

New trio combination

New trio combination is a drug containing 0.1% isobutylamido-thiazolyl-resorcinol, 0.1% retinoic acid and 0.1% dexamethasone

DRUG

Kligman's formula (trio)

Kligman's formula (trio) is a drug containing 5% hydroquinone, 0.1% retinoic acid and 0.1% dexamethason

Sponsors & Collaborators

  • Ghurki Trust and Teaching Hospital

    lead OTHER

Principal Investigators

  • Dr. Meshaal Azhar · Ghurki Trust Teaching Hospital

  • Prof. Dr. Haroon Nabi · Lahore Medical and Dental College

  • Dr Aliza Hamadani · Lahore Medical and Dental College

  • Dr. Iram Kausar · Ghurki Trust Teaching Hospital

  • Dr. Ayesha Asad Chattha · Ghurki Trust Teaching Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-07
Primary Completion
2025-12-07
Completion
2026-01-01

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07676994 on ClinicalTrials.gov