Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata

Официальное название

Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata: Clinical, Dermoscopic and Immunohistochemical Study

Обзор

Alopecia areata (AA) is an autoimmune disorder characterized by non-scarring hair loss of the scalp or any hair-bearing surface. Alopecia areata affects approximately 2% of the general population. AA has a significant influence on patients' quality of life and may induce psychological disorders. In AA, CD4+ and CD8+ T-cells violate the immune privilege of the anagen hair follicle, leading to loss of the growing hair shaft. A genome-wide association study demonstrated a genetic predisposition to AA . Additionally, environmental insults, such as viral infections, trauma, or psychosocial stress, have also been suspected to possibly contribute to the development of the disease . The clinical manifestations of AA vary from small well-defined patches of hair loss to the diffuse involvement of the scalp or the entire body. The majority of AA patients experience unpredictable relapsing and remitting episodes. In a number of patients, it can be persistent, especially when the hair loss is extensive.

Подробное описание

There are many treatment modalities for AA including topical treatment, intralesional injections, systemic corticosteroids, systemic immunosuppressants like methotrexate or cyclosporine, excimer laser and photochemotherapy . To date, the majority of traditional treatments for AA are of limited efficacy with a high risk of adverse effects .

Topical corticosteroids are widely used in the treatment of limited patchy AA and as a first-line therapy for children. They are also recommended as an adjunctive therapy to systemic treatments in more severe forms .

Statins are well known lipid-lowering medications. They have 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.

In several case reports, AA patients were successfully treated with systemic simvastatin . DelCanto, 2020 studied the effect of topical simvastatin in animal model of AA and concluded that it induced hair re-growth, suggesting that it could be a new efficient therapy for AA.

Statins are theorized to induce hair regrowth in AA by inhibiting signal transducers and activators of transcription (STAT) phosphorylation that activates several important inflammatory cytokines and also by altering the balance of Th1/Th2, suppressing IL-17, and inhibiting lymphocyte migration.

Fractional laser has been reported to be successful in treating AA. Fractional CO2 laser is assumed to help in treatment of AA through stimulation of T-cell apoptosis, arrest of hair follicles in the telogen stage, and promotion of the anagen stage. Also, Fractional CO2 laser creates microchannels in the epidermis to improve drug delivery into the skin.

Вмешательства

• Препарат Simvastatin
  Group of patients will be treated by topical application of simvastatin cubosomal nanoparticled twice daily for 6 months, while another group will be treated by fractional CO2 laser for 6 sessions sessions each will be followed immediately by topical application of topical simvastatin.
• Препарат Mometasone Furoate
  Patients will be treated by fractional CO2 laser for 6 sessions each will be followed immediately by topical application of Mometasone Furoate.
• Процедура Fractional CO2 laser
  Fractional CO2 laser will be used for assisted drug delivery for both topical simvastatin and mometasone Furoate.

Первичные конечные точки

• Evaluation of hair regrowth in alopecia areata using SALT score. [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• Patients with patchy alopecia areata involving < 50% of the total scalp.

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 or allergy to any of the treatment products used.
• Patient using treatment (topical or systemic) for alopecia areata in the last 2 months.
• Pregnant and lactating females.
• Patients with history of hypertrophic scars or keloid formation.
• Patients with active infection at the site of the lesion.

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

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Assiut university — Asyut

Публикации

• Adami M, Prudente Ada S, Mendes DA, Horinouchi CD, Cabrini DA, Otuki MF. Simvastatin ointment, a new treatment for skin inflammatory conditions. J Dermatol Sci. 2012 May;66(2):127-35. doi: 10.1016/j.jdermsci.2012.02.015. Epub 2012 Mar 3. PMID 22455735
• Ahmadvand A, Yazdanfar A, Yasrebifar F, Mohammadi Y, Mahjub R, Mehrpooya M. Evaluating the Effects of Oral and Topical Simvastatin in the Treatment of Acne Vulgaris: A Double-blind, Randomized, Placebo-controlled Clinical Trial. Curr Clin Pharmacol. 2018;13(4):279-283. doi: 10.2174/1574884713666180821143545. PMID 30129417
• Al Salman M, Ghiasi M, Farid AS, Taraz M, Azizpour A, Mahmoudi H. Oral simvastatin combined with narrowband UVB for the treatment of psoriasis: A randomized controlled trial. Dermatol Ther. 2021 Sep;34(5):e15075. doi: 10.1111/dth.15075. Epub 2021 Aug 19. PMID 34327798
• Cervantes J, Jimenez JJ, DelCanto GM, Tosti A. Treatment of Alopecia Areata with Simvastatin/Ezetimibe. J Investig Dermatol Symp Proc. 2018 Jan;19(1):S25-S31. doi: 10.1016/j.jisp.2017.10.013. PMID 29273101
• Cheung K, Powers EM, McKillip J, Powers JG. Effect of statin use on incidence of eczema and atopic dermatitis: A retrospective cohort study. J Am Acad Dermatol. 2021 Feb;84(2):534-535. doi: 10.1016/j.jaad.2020.05.015. Epub 2020 May 11. No abstract available. PMID 32407738
• Childs JM, Sperling LC. Histopathology of scarring and nonscarring hair loss. Dermatol Clin. 2013 Jan;31(1):43-56. doi: 10.1016/j.det.2012.08.001. Epub 2012 Sep 26. PMID 23159175
• Cho S, Choi MJ, Zheng Z, Goo B, Kim DY, Cho SB. Clinical effects of non-ablative and ablative fractional lasers on various hair disorders: a case series of 17 patients. J Cosmet Laser Ther. 2013 Apr;15(2):74-9. doi: 10.3109/14764172.2013.764436. Epub 2013 Mar 6. PMID 23464363
• Choi JW, Suh DW, Lew BL, Sim WY. Simvastatin/Ezetimibe Therapy for Recalcitrant Alopecia Areata: An Open Prospective Study of 14 Patients. Ann Dermatol. 2017 Dec;29(6):755-760. doi: 10.5021/ad.2017.29.6.755. Epub 2017 Oct 30. PMID 29200765

Идентификаторы

NCT: NCT06399783 · Sim vs Cs

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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