Study Results
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Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2019-04-01
2021-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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study Metformin 1000 mg
MetFORMIN 1000 Mg Oral Tablet
oral tablet 1ooomg systemic metformin will be given to group
Trichloroacetic Acid Peeling
Trichloroacetic acid peeling to the three groups
study Metformin 500 mg
Trichloroacetic Acid Peeling
Trichloroacetic acid peeling to the three groups
MetFORMIN 500 Mg Oral Tablet
oral tablet 500 mg
control group
Placebos
oral placebos will be given to control beside trichloracetic acid peeling
Trichloroacetic Acid Peeling
Trichloroacetic acid peeling to the three groups
Interventions
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MetFORMIN 1000 Mg Oral Tablet
oral tablet 1ooomg systemic metformin will be given to group
Placebos
oral placebos will be given to control beside trichloracetic acid peeling
Trichloroacetic Acid Peeling
Trichloroacetic acid peeling to the three groups
MetFORMIN 500 Mg Oral Tablet
oral tablet 500 mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. With Fitzpatrick skin phototypes ranging from Type III-V will recruited.
Exclusion Criteria
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,
18 Years
ALL
Yes
Sponsors
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Assiut University
OTHER
Responsible Party
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Karima Nageh
Principle investigator
Locations
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Assuit University
Asyut, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Radwa Bakr
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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MTM
Identifier Type: -
Identifier Source: org_study_id
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