Status:
COMPLETED
Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata
Lead Sponsor:
Cairo University
Conditions:
Alopecia
Alopecia Areata
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Evaluation of the Efficacy and Safety of a drug called Oral Roflumilast versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata.
Detailed Description
we are going to evaluate using oral immunomodulator called Roflumilast and compare its safety and efficacy to intralesional steroid injection in the treatment of Alopecia areata
Eligibility Criteria
Inclusion
- Patients with mild to moderate patchy alopecia areata as assessed by SALT score (S1: 1-24% hair loss (limited); S2: 25-49% hair loss (moderate))
- Patients with patchy alopecia areata with viable hair follicles by trichoscopy.
- Patients of both genders aged \>18 years.
- Patients able and willing to provide informed consent.
Exclusion
- Patients with other types of AA (surface area \>50%, alopecia totalis, alopecia universalis and ophiasis).
- Patients less than 18 years old.
- Patients receiving systemic treatment relevant to AA or biologics, phototherapy, or topical treatment within 4 weeks before enrollment into the study.
- Patients with a history of/ or existing scalp skin diseases apart from AA, such as eczema, seborrheic dermatitis, psoriasis, scalp infections, or skin cancer.
- Pregnant and lactating females.
- Patients with a history of other inflammatory skin conditions
- History of hypersensitivity to roflumilast or its components.
- History of severe anxiety or depression (Gupta, 2012)
- Patients with history of bleeding disorders or on anticoagulant medications,
- Patients with active infection at the local site, patients with keloidal tendency, and patients with low pain threshold.
Key Trial Info
Start Date :
January 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07174011
Start Date
January 12 2025
End Date
August 20 2025
Last Update
September 15 2025
Active Locations (1)
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1
Cairo University
Giza, Cairo Governorate, Egypt, 13114