Topical Simvastatin Versus Topical Steroid in Treatment of Alopecia Areata

NCT06399783 | Not Yet Recruiting Phase 4

• 1 other identifier: Sim vs Cs
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia Areata

Outcome Measures

Primary Outcomes (1)

• Evaluation of hair regrowth in alopecia areata using SALT score.

  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.

  24 weeks

Interventions

Simvastatin DRUG

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 DRUG

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 PROCEDURE

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

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university

Asyut, 73333, Egypt

Location

Related Publications (26)

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MeSH Terms

Conditions

Alopecia Areata

Interventions

Simvastatin; Mometasone Furoate

Condition Hierarchy (Ancestors)

Alopecia; Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Central Study Contacts

Hana A Morsy, professor

CONTACT

00201064447881; hanan_morsy2003@yahoo.com

Reham Maher, Assistant professor

CONTACT

00201005043777; Rehamaher@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)