Clinical trial NCT06399783: Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata
Official title: Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata: Clinical, Dermoscopic and Immunohistochemical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Alopecia Areata
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 54
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be divided randomly into three groups:

Group A: Patients will be treated by topical application of simvastatin cubosomal nanoparticled twice daily for 6 months.

Group B: Patients will be treated by fractional CO2 laser for 6 sessions sessions each will be followed immediately by topical application of topical simvastatin.

Group C: Patients will be treated by fractional CO2 laser for 6 sessions each will be followed immediately by topical application of topical steroid.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Evaluation of hair regrowth in alopecia areata using SALT score.
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
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