Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata
Not Applicable
Completed
- Conditions
- AlopeciaAlopecia Areata
- Interventions
- Drug: intralesional steroid
- Registration Number
- NCT07174011
- Lead Sponsor
- Cairo University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A: 25 participants with AA will be on Roflumilast group Roflumilast patients in arm A will receive daily oral Roflumilast (immunomodulator) 500 mcg for 16Consecutive weeks. 25 participants will receive intralesional steroid injection intralesional steroid ILCs group: 5 mg/mL every 4 weeks for 16 weeks
- Primary Outcome Measures
Name Time Method To assess the degree of improvement in hair regrowth according to the change in SALT score from baseline to Week 16. 4 months To assess the degree of improvement in hair regrowth according to the change in SALT score from baseline to Week 16.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cairo University
🇪🇬Giza, Cairo Governorate, Egypt
Cairo University🇪🇬Giza, Cairo Governorate, Egypt