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Completed

NCT Number: NCT07174011

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

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Key information

Age range

18 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cairo University

Giza, Cairo Governorate, 13114, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Roflumilast

Drug

Phosphodiesterase-4 (PDE4) inhibitor assigned to arm A

intralesional steroid

Drug

intralesional injection of corticosteroid

Primary outcomes

  1. 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

    To assess the degree of improvement in hair regrowth according to the change in SALT score from baseline to Week 16.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: AA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 15, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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