New Topical Treatment in Patchy Alopecia Areata

Официальное название

Efficacy and Safety of Topical Therapy of Metformin 30%; Simvastatin 2%; and Betamethasone Valerate 0.1% in Treatment of Patients With Patchy Alopecia Areata

Обзор

Alopecia areata (AA) is a chronic immune disease characterized by non-scarring hair loss of the scalp or other hair-bearing areas Patients with AA frequently report high levels of dissatisfaction with commonly used treatment options due to ineffectiveness and adverse effects. Therefore, a substantial unmet need exists for safe and effective treatments for patients with AA. Metformin is a derivative of biguanide that is the most widely used as an oral antihyperglycemic agent for the control of diabetes mellitus. The main mechanism of action for metformin involves enhancing insulin sensitivity, reducing gluconeogenesis, and promoting the absorption of glucose in muscles. In addition to its hypoglycemic effect, metformin can serve as an anti-inflammatory agent.Statins are hydroxy-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, commonly used for their lipid-lowering properties to lower cholesterol levels and treat cardiovascular disease, but they also possess powerful anti-inflammatory and immunomodulatory effects. Simvastatin belongs to the statin family. Lately, Simvastatin is utilized in treatment of several dermatological diseases. It showed efficacy in treatment of psoriasis , vitiligo, xanthomas, atopic dermatitis and acne vulgaris. This study is considered as the first study to assess and compare the efficacy and safety of of topical therapy of metformin 30 %; simvastatin 2 %; and betamethasone valerate 0.1 % in treatment of patients with patchy alopecia areata.

Вмешательства

• Препарат topical metformin 30% ointment
  each patient will use topical metformin 30% ointment twice daily for 12 weeks. oPreparation of metformin 30% ointment: Weighing 30 gm standard metformin ( E. Merck ) supplied by chemtech. then grinding the powder with a suitable wetting agent (e.g., propylene glycol) to form a smooth paste, followed by incorporation into an appropriate ointment base using geometric dilution until uniform distribution is achieved. The final product will be packed in an airtight container and stored at room temper
• Препарат Topical Simvastatin 2% ointment
  each patient (age, sex matched) will use topical simvastatin 2% ointment twice daily for 12 weeks. Preparation of simvastatin 2% ointment: Simvastatin powder will be levigated or solubilized in propylene glycol prior to incorporation into a white soft paraffin, using geometric dilution to ensure uniform distribution. The final formulation will be stored in a light-resistant container at room temperature
• Препарат Topical betamethasone valerate 0.1% ointment
  each patient (age, sex matched) will use topical betamethasone valerate 0.1% ointment twice daily for 12 weeks. oManufactured by Egyptian international pharmaceutical industries co. E.I.P.I.C.O. and will be purchased from local pharmacy, Sohag, Egypt.

Первичные конечные точки

• hair regrowth in alopecia patch [Срок оценки: baseline, weeks 4, 8 and 12 (end of treatment) and 3 month after treatment completion]

Критерии участия

Критерии включения

\- Patients of both sexes aged ≥ 6 years (children and adults), having clinical and trichscopic finding of alopecia areata (involving < 50% of the total scalp) and did not receive any topical or systemic treatment in the last 3 months for alopecia areata.

Критерии исключения

• Alopecia totalis and alopecia universalis.
• Cicatricial alopecia.
• Other causes of hair loss such as; endocrine or immunological disease.
• Skin disease in the affected area.
• Hypersensitivity to any of the treatment products used.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07696585 · Soh-Med--26-6-1MD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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