Back to resultsComparison of 30% Metformin and 2% Nicotinamide Lotion With Kligman Formula in the Treatment of Melasma
Primary Purpose
Melasma
Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
Metformin and Nicotinamide vs Kligman Formula
Sponsored by
About this trial
This is an interventional treatment trial for Melasma
Eligibility Criteria
Inclusion Criteria: Age between 18-50 No systemic therapy All Co-morbids Exclusion Criteria: Pregnancy Age >50 Taking oral treatment for melasma
Sites / Locations
- PakEmiratesMH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Metformin 30% and 2% Nicotinamispde
Kligman formula
Arm Description
Metformin 30% plus Nicotinamide 2% in the reatment of Melasma
Kligman formula in the treatment of Melasma
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05790577
Brief Title
Comparison of 30% Metformin and 2% Nicotinamide Lotion With Kligman Formula in the Treatment of Melasma
Official Title
Comparison of 30% Metformin and 2% Nicotinamide Lotion With Kligman Formula in the Treatment of Melasma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 15, 2023 (Actual)
Study Completion Date
February 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ishtiaq Ahmed
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma
Detailed Description
A comparative study to evaluate Efficacy and tolerability of new lotion in the treatment of Melasma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melasma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin 30% and 2% Nicotinamispde
Arm Type
Active Comparator
Arm Description
Metformin 30% plus Nicotinamide 2% in the reatment of Melasma
Arm Title
Kligman formula
Arm Type
Active Comparator
Arm Description
Kligman formula in the treatment of Melasma
Intervention Type
Drug
Intervention Name(s)
Metformin and Nicotinamide vs Kligman Formula
Intervention Description
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma
Primary Outcome Measure Information:
Title
Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma
Description
Efficacy with measurement of MASI score 4 weeks apart
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age between 18-50
No systemic therapy
All Co-morbids
Exclusion Criteria:
Pregnancy
Age >50
Taking oral treatment for melasma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ishtiaq Ahmed, MBBS
Organizational Affiliation
Pak Emirates Military Hospital
Official's Role
Study Director
Facility Information:
Facility Name
PakEmiratesMH
City
Rawalpindi
State/Province
Punjab
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of 30% Metformin and 2% Nicotinamide Lotion With Kligman Formula in the Treatment of Melasma
We'll reach out to this number within 24 hrs