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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03475524
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : August 3, 2021
Information provided by (Responsible Party):
Karima Nageh, Assiut University

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.

Condition or disease Intervention/treatment Phase
Melasma Drug: MetFORMIN 1000 Mg Oral Tablet Drug: Placebos Drug: Trichloroacetic Acid Peeling Drug: MetFORMIN 500 Mg Oral Tablet Phase 4

Detailed Description:

Its pathogenesis is not fully understood, nevertheless there is evidence that melanogenesis in melasma differ from tanning and post-inflammatory hyperpigmentations as well as there is an involvement of the whole epidermal melanin unit in the process (not just hypertrophic melanocytes), mastocytes, fibroblast and endothelium derived cytokines, as well as there are upper dermal abnormalities different from other acquired pigmentary disorders. Patients with melasma have also been found to have higher markers of oxidative stress status.

Melasma has significant impact on patients physical health, interpersonal relationships ,social-well being and self- esteem as they refused to leave their house, felt inferior to others, and incessantly thought about their melasma being.

Melasma is often resistant to treatment and frustrating for both patients and clinician. In spite of presence of several methods for treatment of melasma exacted as, Topical compounds that include the Kligman's formula which is the triple combination of ( retinoid, hydroquinone, and steroid) and azelaic. Chemical peels (e.g., glycolic, β hydroxyl, and trichloroacetic acid )although these must be used cautiously in patients with darker skin. Laser and Light therapies represent potentially promising options for patients who are refractory to other modalities, but they also carry significant risk of worsening the disease.

Recently, some reports refer to the use of metformin in treatment of melasma. Metformin is antidiabetic drugs that was shown to exert its biological effect by decreasing cyclic adenosine phosphate , which is a well known modulator of melanin synthesis. Metformin decreased skin pigmentation in vivo with minimal side effects, suggesting a potential application of metformin in the treatment of hyperpigmentation disorders. Where the metformin was applied topically onto a mouse tail, whitening of the tail was observed. In addition, metformin decreased the epidermal level of melanin when metformin was applied to human skin punch biopsies and to reconstructed human epidermis. When melanocytes were treated with metformin, basal level of total melanin (eumelanin and pheomelanin) were reduced significantly. Also metformin blocked forskolin and alpha melanocyte-stimulating hormone which increase the levels of melanin. Metformin decrease levels of tyrosinase, tyrosinase-related protein-1 and tyrosinase-related protein-2.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: study Metformin 1000 mg Drug: MetFORMIN 1000 Mg Oral Tablet
oral tablet 1ooomg systemic metformin will be given to group
Other Name: Glucophage

Drug: Trichloroacetic Acid Peeling
Trichloroacetic acid peeling to the three groups

Experimental: study Metformin 500 mg Drug: Trichloroacetic Acid Peeling
Trichloroacetic acid peeling to the three groups

Drug: MetFORMIN 500 Mg Oral Tablet
oral tablet 500 mg
Other Name: Glucophage

Placebo Comparator: control group Drug: Placebos
oral placebos will be given to control beside trichloracetic acid peeling

Drug: Trichloroacetic Acid Peeling
Trichloroacetic acid peeling to the three groups

Primary Outcome Measures :
  1. degree of improvement of melasma [ Time Frame: up to 3 months ]

    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  1. Pregnant or nursing women.
  2. 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.
  3. Occupation involving primarily outdoor activities.
  4. 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).
  5. 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).
  6. Photosensitivity,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03475524

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Contact: Sahar Ismail, professor 01007074449
Contact: Radwa Bakr, lecturer 01119988115

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Assuit University Recruiting
Assiut, Egypt, 71111
Contact: Radwa Bakr    01119988115      
Contact: sahar Ismail   
Sponsors and Collaborators
Assiut University
Publications of Results:

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Responsible Party: Karima Nageh, Principle investigator, Assiut University Identifier: NCT03475524    
Other Study ID Numbers: MTM
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pigmentation Disorders
Skin Diseases
Hypoglycemic Agents
Physiological Effects of Drugs