NCT05790577

Brief Summary

Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

August 6, 2022

Last Update Submit

May 22, 2023

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

  • Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma

    Efficacy with measurement of MASI score 4 weeks apart

    12 weeks

Study Arms (2)

Metformin 30% and 2% Nicotinamispde

ACTIVE COMPARATOR

Metformin 30% plus Nicotinamide 2% in the reatment of Melasma

Drug: Metformin and Nicotinamide vs Kligman Formula

Kligman formula

ACTIVE COMPARATOR

Kligman formula in the treatment of Melasma

Drug: Metformin and Nicotinamide vs Kligman Formula

Interventions

Metformin and Nicotinamide vs Kligman FormulaDRUG

Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma

Kligman formulaMetformin 30% and 2% Nicotinamispde

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PakEmiratesMH

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Melanosis

Interventions

Metformin

Condition Hierarchy (Ancestors)

HyperpigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • Ishtiaq Ahmed, MBBS

    Pak Emirates Military Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ishtiaq Ahmed

Study Record Dates

First Submitted

August 6, 2022

First Posted

March 30, 2023

Study Start

February 1, 2022

Primary Completion

February 15, 2023

Study Completion

February 15, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)