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

NCT07174011 | Completed Phase 4 DMC

• 1 other identifier: MS-79-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia; Alopecia Areata

Keywords

Intralesional Corticosteroids Injection (ILCs); Roflumilast; Alopecia areata

Outcome Measures

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.

  4 months

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: Roflumilast

25 participants will receive intralesional steroid injection

ACTIVE COMPARATOR

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

Drug: intralesional steroid

Interventions

Roflumilast DRUG

Phosphodiesterase-4 (PDE4) inhibitor assigned to arm A

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

intralesional steroid DRUG

intralesional injection of corticosteroid

25 participants will receive intralesional steroid injection

Eligibility Criteria

• Age: 18 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Cairo Governorate, 13114, Egypt

Location

MeSH Terms

Conditions

Alopecia; Alopecia Areata

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: January 12, 2025
• Primary Completion: May 20, 2025
• Study Completion: August 20, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)