Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata

Sponsor
Cairo University
Study ID
NCT07174011
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Weeks - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    Phosphodiesterase-4 (PDE4) inhibitor assigned to arm A
  • intralesional steroid — DRUG
    intralesional injection of corticosteroid

Study Details

Evaluation of the Efficacy and Safety of a drug called Oral Roflumilast versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata.

Key Dates

Start date
Jan 12, 2025
Status verified
Sep 2025
Primary completion
May 20, 2025
Completion
Aug 20, 2025

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: 25 participants with AA will be on Roflumilast group
    patients in arm A will receive daily oral Roflumilast (immunomodulator) 500 mcg for 16Consecutive weeks.
  • Active Comparator: 25 participants will receive intralesional steroid injection
    ILCs group: 5 mg/mL every 4 weeks for 16 weeks

Primary Outcome Measure

To assess the degree of improvement in hair regrowth according to the change in SALT score from baseline to Week 16. [ Time Frame: 4 months ]

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