CompletedPhase 4
Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata
Key facts
- Who runs it
- Cairo University
- Where
- Egypt1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 4
- People taking part
- 50 people enrolled
- Started
- 12 Jan 2025
- Ended
- 20 Aug 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Roflumilast
- intralesional steroid
- Record updated
- 15 September 2025
Who can take part
- Age
- 18 weeks and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Patients less than 18 years old
- Patients with other types of AA (surface area \>50%, alopecia totalis, alopecia universalis and ophiasis)
- Pregnant and lactating females
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Evaluation of the Efficacy and Safety of a drug called Oral Roflumilast versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata.
The 2 groups in the trial
- Arm A: 25 participants with AA will be on Roflumilast groupExisting treatment, for comparison
patients in arm A will receive daily oral Roflumilast (immunomodulator) 500 mcg for 16Consecutive weeks.
Treatment: Roflumilast
- 25 participants will receive intralesional steroid injectionExisting treatment, for comparison
ILCs group: 5 mg/mL every 4 weeks for 16 weeks
Treatment: intralesional steroid
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official 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.
- Record updated
- 15 September 2025