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Completed

NCT Number: NCT07676994

Efficacy of New Trio Combination for Melasma

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.

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Key information

Conditions

Melasma Hyperpigmentation Melanosis Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ghurki Trust Teaching Hospital

Lahore, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

New trio combination

Drug

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

Primary outcomes

  1. Melasma Quality of Life (MELASQoL)

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

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

  2. 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.

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

Sponsors and collaborators

Lead sponsor

Ghurki Trust and Teaching Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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