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Clinical Trials in Egypt / NCT06399783
Starting soon Phase 4

Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata

NCT06399783 · tracked via the Priya Life Science Egypt tracker
Sponsor
Assiut University
Phase
Phase 4
Started
2024-10-01
Last updated
2024-05-06

Condition(s) studied

Alopecia Areata

Investigational drug(s) / intervention(s)

Simvastatin →Mometasone Furoate →Fractional CO2 laser

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.

Mometasone Furoate: Patients will be treated by fractional CO2 laser for 6 sessions each will be followed immediately by topical application of Mometasone Furoate.

Fractional CO2 laser: Fractional CO2 laser will be used for assisted drug delivery for both topical simvastatin and mometasone Furoate.

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
60 Years
Healthy volunteers
No
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 outcome measure(s)

  • Evaluation of hair regrowth in alopecia areata using SALT score. — 24 weeks
    The scalp is divided into four parts on the basis of surface area as follows: vertex or top = 40% (0.40), right side = 18% (0.18), left side = 18% (0.18) and the posterior aspect = 24% (0.24). Percentage of hair loss in any of the four areas is multiplied by the percentage of the scalp covered in that area. The SALT score is the sum of the percentage of hair loss in all the areas mentioned above.

Trial sites (1)

FacilityCityRegionStatus
Assiut university Asyut Egypt

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Other trials for the same condition

Combined Microneedling With Either 1% Lactic Acid Solution or Vitamin D3 or Triamcinolone Acetonide in The Treatment of Alopecia Areata Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06399783 on ClinicalTrials.gov ↗ ← All trials in Egypt