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

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Alopecia; Alopecia Areata

Treatments: Drug: Roflumilast; Drug: intralesional steroid

Study type: Interventional

Funder types: Other

Identifiers

NCT07174011

MS-79-2025

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 18+ weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Arm A: 25 participants with AA will be on Roflumilast group

Active Comparator group

Description:

patients in arm A will receive daily oral Roflumilast (immunomodulator) 500 mcg for 16Consecutive weeks.

Treatment:

Drug: Roflumilast

25 participants will receive intralesional steroid injection

Active Comparator group

Description:

ILCs group: 5 mg/mL every 4 weeks for 16 weeks

Treatment:

Drug: intralesional steroid