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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-12

Study Completion Date

2025-08-20

Brief Summary

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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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Detailed Description

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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

Conditions

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Alopecia Alopecia Areata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Roflumilast

Intervention Type DRUG

Phosphodiesterase-4 (PDE4) inhibitor assigned to arm A

25 participants will receive intralesional steroid injection

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

Group Type ACTIVE_COMPARATOR

intralesional steroid

Intervention Type DRUG

intralesional injection of corticosteroid

Interventions

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Roflumilast

Phosphodiesterase-4 (PDE4) inhibitor assigned to arm A

Intervention Type DRUG

intralesional steroid

intralesional injection of corticosteroid

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No