Clinical TrialID 6628

USE THE SYSTEMIC METFORMIN IN MELASMA

NCT03475524

Melasma

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Record Fields

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Clinical Trial Id
6628
Evidence Id
6628
Core Evidence Id
6628
Source Clinical Trial Id
6615
Herb2 Clinical Trial Id
HBCT006615
Nct Id
NCT03475524
Title
USE THE SYSTEMIC METFORMIN IN MELASMA
Status
Phase
Phase 4
Study Result
No
Study Condition
Melasma
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: MetFORMIN 1000 Mg Oral Tablet|DRUG: Placebos|DRUG: Trichloroacetic Acid Peeling|DRUG: MetFORMIN 500 Mg Oral Tablet
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
60
Outcome Measure
degree of improvement of melasma, Melasma Area and Severity Index score will be calculated for patients before and after treatment to all patientsscore is calculated by multiplying the area of involvement with the square of pigmentation as given in the formula: MSI = 0.4 (a × p 2 ) l + 0.4 (a × p 2 ) r + 0.2 (a × p 2 ) n In the formula, "a" stands for "area of involvement," "p" for "severity of pigmentation," "l" for left face, "r" for right face, and "n" for nose. The area involved, as well as the severity of pigmentation is scored from 0 to 4Score 0:No visible pigmentation,score 1 :rarely visible pigmentation scor e 2:mild pigmentation score3: moderate pigmentation score 4:sever pigmentation.scoringfor area of involvement less than or equal 10% area involved-scor1,11-30%-score2 ,31-60%-score3 and more than 60%-score 4 . patient will be photographed at baseline and after every two weeks interval and one month after the last session, up to 3 months
Sponsor Collaborator
Assiut University
Funded By
OTHER
Location
Assuit University, Assiut, 71111, Egypt
Other Id
MTM
Start Date
2019-04-01
Primary Completion Date
2021-08
Completion Date
2021-08
First Posted
2018-03-23
Results First Posted
Last Update Posted
2021-08-03
Study Document
Study Url
https://clinicaltrials.gov/study/NCT03475524
Title Cn
Title En
USE THE SYSTEMIC METFORMIN IN MELASMA
Bilingual Status
semi_complete