USE THE SYSTEMIC METFORMIN IN MELASMA

NCT03475524 | Unknown Phase 4

• 1 other identifier: MTM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Melasma is a chronic and relapsing acquired dyschromia due to an increased epidermal-melanin unit activity that affects sun-exposed areas mainly in women throughout the reproductive years. It is more common in women, accounting for 90% of all cases.The majority of patients are in third and fourth decades of their life. There are several risk factors that influence its appearance including genetic predisposition,exposure to heat and UV radiation, pregnancy, and exogenous hormones (such as oral contraceptives,thyroid hormones, and hormone replacement therapy). Other factors implicated are phototoxic drugs, anticonvulsant medications,and the use of certain cosmetics. Types of melasma are epidermal, dermal and mixed according to location of melanin.

Conditions

Melasma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

study Metformin 1000 mg

EXPERIMENTAL

Drug: MetFORMIN 1000 Mg Oral Tablet; Drug: Trichloroacetic Acid Peeling

study Metformin 500 mg

EXPERIMENTAL

Drug: Trichloroacetic Acid Peeling; Drug: MetFORMIN 500 Mg Oral Tablet

control group

PLACEBO COMPARATOR

Drug: Placebos; Drug: Trichloroacetic Acid Peeling

Interventions

MetFORMIN 1000 Mg Oral Tablet DRUG

oral tablet 1ooomg systemic metformin will be given to group

Also known as: Glucophage

study Metformin 1000 mg

Placebos DRUG

oral placebos will be given to control beside trichloracetic acid peeling

control group

Trichloroacetic Acid Peeling DRUG

Trichloroacetic acid peeling to the three groups

control group; study Metformin 1000 mg; study Metformin 500 mg

MetFORMIN 500 Mg Oral Tablet DRUG

oral tablet 500 mg

Also known as: Glucophage

study Metformin 500 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients above 18 years old with melasma.
• With Fitzpatrick skin phototypes ranging from Type III-V will recruited.

You may not qualify if:

• Pregnant or nursing women.
• Current use of hormonal birth control medication or any hormonal therapy, Use of topical hydroquinone within 3 months of study, Use of topical steroids within 1 month of study, Regular use of tanning parlors and History of laser or dermabrasion to the face within 9 months of study.
• Occupation involving primarily outdoor activities.
• History of kidney dysfunction diabetic (excluded by history and laboratory), Significant cardiovascular or respiratory disease and any other systemic diseases(i.e,history of endocrine disorders).
• patients with poor wound healing, recurrent herpes labialis and current skin infection (facial warts, molluscum contagiosum, history of hypertrophic scar/keloids, active dermatosis of atopic, seborrheic or other eczematous type).
• Photosensitivity,

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit University

Asyut, 71111, Egypt

RECRUITING

Related Publications (10)

• Handel AC, Miot LD, Miot HA. Melasma: a clinical and epidemiological review. An Bras Dermatol. 2014 Sep-Oct;89(5):771-82. doi: 10.1590/abd1806-4841.20143063.

  PMID: 25184917 RESULT

• Moubasher AE, Youssef EM, Abou-Taleb DA. Q-switched Nd: YAG laser versus trichloroacetic acid peeling in the treatment of melasma among Egyptian patients. Dermatol Surg. 2014 Aug;40(8):874-82. doi: 10.1097/DSS.0000000000000065.

  PMID: 25068546 RESULT

• Brianezi G, Handel AC, Schmitt JV, Miot LD, Miot HA. Changes in nuclear morphology and chromatin texture of basal keratinocytes in melasma. J Eur Acad Dermatol Venereol. 2015 Apr;29(4):809-12. doi: 10.1111/jdv.12453. Epub 2014 Mar 14.

  PMID: 24629163 RESULT

• Kong SH, Suh HS, Choi YS. Treatment of Melasma with Pulsed-Dye Laser and 1,064-nm Q-Switched Nd:YAG Laser: A Split-Face Study. Ann Dermatol. 2018 Feb;30(1):1-7. doi: 10.5021/ad.2018.30.1.1. Epub 2017 Dec 26.

  PMID: 29386825 RESULT

• Lehraiki A, Abbe P, Cerezo M, Rouaud F, Regazzetti C, Chignon-Sicard B, Passeron T, Bertolotto C, Ballotti R, Rocchi S. Inhibition of melanogenesis by the antidiabetic metformin. J Invest Dermatol. 2014 Oct;134(10):2589-2597. doi: 10.1038/jid.2014.202. Epub 2014 Apr 22.

  PMID: 24756109 RESULT

• Sarkar R, Arora P, Garg VK, Sonthalia S, Gokhale N. Melasma update. Indian Dermatol Online J. 2014 Oct;5(4):426-35. doi: 10.4103/2229-5178.142484.

  PMID: 25396123 RESULT

• Sheth VM, Pandya AG. Melasma: a comprehensive update: part I. J Am Acad Dermatol. 2011 Oct;65(4):689-697. doi: 10.1016/j.jaad.2010.12.046.

  PMID: 21920241 RESULT

• Sheth VM, Pandya AG. Melasma: a comprehensive update: part II. J Am Acad Dermatol. 2011 Oct;65(4):699-714. doi: 10.1016/j.jaad.2011.06.001.

  PMID: 21920242 RESULT

• Majid I, Haq I, Imran S, Keen A, Aziz K, Arif T. Proposing Melasma Severity Index: A New, More Practical, Office-based Scoring System for Assessing the Severity of Melasma. Indian J Dermatol. 2016 Jan-Feb;61(1):39-44. doi: 10.4103/0019-5154.174024.

  PMID: 26955093 RESULT

• Ismail SA, Mohamed GA, Mohamedeen KN, Sotohy RSA, Bakr RM. Does Systemic Metformin Have a Role in Treating Melasma? Dermatol Surg. 2024 Apr 1;50(4):366-371. doi: 10.1097/DSS.0000000000004092. Epub 2024 Feb 28.

  PMID: 38416809 DERIVED

MeSH Terms

Conditions

Melanosis

Interventions

Metformin; Tablets

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Sahar Ismail, professor

CONTACT

01007074449; saharsotohy@yahoo.com

Radwa Bakr, lecturer

CONTACT

01119988115; Radwabakr2011@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 23, 2018
• Study Start: April 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-08

Locations

EG (1)