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Pill vs. needle: can roflumilast regrow hair in alopecia areata?

NCT ID NCT07174011

Disease control Sponsor: Cairo University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This completed trial tested whether an oral anti-inflammatory drug called roflumilast can regrow hair as well as steroid injections in people with mild-to-moderate patchy alopecia areata. Fifty adults with limited to moderate hair loss were enrolled. The main goal was to measure hair regrowth using the SALT score after 16 weeks of treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
roflumilast (an oral anti-inflammatory drug) and intralesional corticosteroid injections (steroid shots into the scalp)
What this could lead to
If roflumilast works as well as steroid injections, it could provide a pill-based alternative for treating patchy hair loss from alopecia areata.
What could go wrong
This is a small, completed Phase 4 trial with only 50 participants. Results may not apply to more severe forms of alopecia areata, and roflumilast may have side effects like nausea or headache.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

50 people

The number who actually took part.

Started

Jan 2025

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 weeks and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

alopecia alopecia areata

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alopecia Alopecia areata

Contacts and locations

Locations

  • Cairo University

    Giza, Cairo Governorate, 13114, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.