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COMPLETED
NCT07676994
PHASE4

Efficacy of New Trio Combination for Melasma

Sponsor: Ghurki Trust and Teaching Hospital

View on ClinicalTrials.gov

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.

Official title: Efficacy of New Trio Combination Versus Kligman's Formula In Treatment of Melasma

Key Details

Gender

FEMALE

Age Range

16 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2025-05-07

Completion Date

2026-01-01

Last Updated

2026-06-30

Healthy Volunteers

No

Conditions

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

Locations (1)

Ghurki Trust Teaching Hospital

Lahore, Pakistan