Comparison of 30% Metformin and 2% Nicotinamide Lotion With Kligman Formula in the Treatment of Melasma

May 22, 2023 updated by: Ishtiaq Ahmed
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A comparative study to evaluate Efficacy and tolerability of new lotion in the treatment of Melasma.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan
        • PakEmiratesMH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between 18-50
  • No systemic therapy
  • All Co-morbids

Exclusion Criteria:

  • Pregnancy
  • Age >50
  • Taking oral treatment for melasma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metformin 30% and 2% Nicotinamispde
Metformin 30% plus Nicotinamide 2% in the reatment of Melasma
Drug: Metformin and Nicotinamide vs Kligman Formula
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma
Active Comparator: Kligman formula
Kligman formula in the treatment of Melasma
Drug: Metformin and Nicotinamide vs Kligman Formula
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma
Time Frame: 12 weeks
Efficacy with measurement of MASI score 4 weeks apart
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ishtiaq Ahmed

Investigators

  • Study Director: Ishtiaq Ahmed, MBBS, Pak Emirates Military Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

February 15, 2023

Study Completion (Actual)

February 15, 2023

Study Registration Dates

First Submitted

August 6, 2022

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PakEmiratesMH2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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