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

Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata: A Randomized Controlled Trial.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07174011

Acronym

Enrollment

Registered

2025-09-15

Start date

2025-01-12

Completion date

2025-08-20

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alopecia, Alopecia Areata

Keywords

Intralesional Corticosteroids Injection (ILCs), Roflumilast, Alopecia areata

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

Interventions

DRUGRoflumilast

Phosphodiesterase-4 (PDE4) inhibitor assigned to arm A

DRUGintralesional steroid

intralesional injection of corticosteroid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Weeks to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026