Efficacy of New Trio Combination for Melasma

Ghurki Trust and Teaching Hospital

Status and phase: Completed; Phase 4

Conditions: Melasma

Treatments: Drug: New trio combination; Drug: Kligman's formula (trio)

Study type: Interventional

Funder types: Other

Identifiers

NCT07676994

R-22

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: Female

Ages: 16 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Intervention Group: Group A

Experimental group

Description:

Group A will receive New trio combination (NT) once daily

Treatment:

Drug: New trio combination

Control Group: Group B

Active Comparator group

Description:

Group B will receive Kligman's formula (KG), once daily

Treatment:

Drug: Kligman's formula (trio)