Efficacy of New Trio Combination for Melasma

Ghurki Trust and Teaching Hospital56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Melasma

Interventions

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

Kligman's formula (trio)DRUG

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

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female gender * Age range: 16-60 years Exclusion Criteria: * Pregnant females * Lactating mothers * Those taking oral contraceptive pills and phenytoin * Lost to follow up

Locations (1)

Ghurki Trust Teaching Hospital

Lahore, Pakistan

Outcomes

Primary Outcomes

Melasma Quality of Life (MELASQoL)

Melasma Quality of Life Scale (MELASQoL) will be used to assess the burden of melasma on patient's quality of life.

Time frame: Responses will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks

modified Melasma Area and Severity Index (mMASI)

Melasma severity will be assessed by modified Melasma Area and Severity Index (mMASI).

Time frame: Melasma severity over the course of 12 weeks of treatment, with responses assessed at baseline, 4 weeks, 8 weeks, and 12 weeks.

Data from ClinicalTrials.gov

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