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

Sponsor

Ishtiaq Ahmed (Other)

Overall Status

Completed

CT.gov ID

NCT05790577

Collaborator

(none)

120

Enrollment

Location

Arms

8.5

Actual Duration (Months)

14.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Melasma	Drug: Metformin and Nicotinamide vs Kligman Formula	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Actual Primary Completion Date :

Feb 15, 2023

Actual Study Completion Date :

Feb 15, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma [12 weeks]
Efficacy with measurement of MASI score 4 weeks apart

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Pregnancy
Age >50
Taking oral treatment for melasma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PakEmiratesMH	Rawalpindi	Punjab	Pakistan

Sponsors and Collaborators

Ishtiaq Ahmed

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ishtiaq Ahmed, Ishtiaq Ahmed, Pak Emirates Military Hospital

ClinicalTrials.gov Identifier:

NCT05790577

Other Study ID Numbers:

PakEmiratesMH2

First Posted:

Mar 30, 2023

Last Update Posted:

Mar 30, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 30, 2023