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CompletedNCT07174011AAUpdated Sep 15, 2025

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

A Phase 4 interventional study of Roflumilast and intralesional steroid in Alopecia and Alopecia Areata, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Weeks and older. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Cairo University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2025, registered Sep 2025).
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Weeks and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Alopecia
  • Alopecia Areata

Keywords

  • Intralesional Corticosteroids Injection (ILCs)
  • Roflumilast
  • Alopecia areata
03

In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's enrollment of 50 is above the median of 45 across 513 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Weeks and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

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

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

    Drug: Roflumilast

  • Active comparator
    25 participants will receive intralesional steroid injection

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

    Drug: intralesional steroid

Interventions

  • DrugRoflumilast

    Phosphodiesterase-4 (PDE4) inhibitor assigned to arm A

  • Drugintralesional steroid

    intralesional injection of corticosteroid

06

What researchers measure

Primary outcomes

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

    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

07

Study locations

1 site
  • Cairo University
    Giza, Cairo Governorate 13114, Egypt
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References and documents

Individual participant data

Plan to share: Yes — age, sex

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07174011
Lead sponsor
Cairo University
Responsible party
Nahla Maher Mahmoud Mahran (Lecturer of Dermatology, Cairo University) — Principal investigator
First posted
Sep 15, 2025
Start date
Jan 12, 2025
Primary completion
May 20, 2025
Completion
Aug 20, 2025
Last update
Sep 15, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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