AlopeciaPhase 4AANCT07174011
Evaluation of the Efficacy and Safety of Oral Roflumilast Versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata
A Phase 4 study testing Roflumilast and intralesional steroid in people with Alopecia and Alopecia Areata, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 weeks and older
- Conditions the study is for
- Alopecia, Alopecia Areata
- What is being tested?
- Roflumilast and intralesional steroid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2025to 20 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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
- Conditions
- Alopecia, Alopecia Areata
- Being tested
- Roflumilast, intralesional steroid
- Keywords
- Intralesional Corticosteroids Injection (ILCs), Roflumilast, Alopecia areata
- Medical subject headings
- Alopecia, Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoflumilastDrug
Phosphodiesterase-4 (PDE4) inhibitor assigned to arm A
intralesional steroidDrug
intralesional injection of corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Roflumilast |
| 25 participants will receive intralesional steroid injection | Active comparator | ILCs group: 5 mg/mL every 4 weeks for 16 weeks Receives: Drug: intralesional steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start12 Jan 2025
- Primary completion20 May 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Maher Mahmoud Mahran, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174011
- Sponsor's protocol ID
- MS-79-2025
- Acronym
- AA
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: age, sex
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07174011
- Acronym / sponsor ID
- AA / MS-79-2025
- Conditions
- Alopecia, Alopecia Areata
- Keywords
- Intralesional Corticosteroids Injection (ILCs), Roflumilast, Alopecia areata
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jan 2025 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the Efficacy and Safety of a drug called Oral Roflumilast versus Intralesional Corticosteroids Injection (ILCs) in the Treatment of Alopecia Areata.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: 25 participants with AA will be on Roflumilast group | Active comparator | Drug: Roflumilastpatients in arm A will receive daily oral Roflumilast (immunomodulator) 500 mcg for 16Consecutive weeks. |
| 25 participants will receive intralesional steroid injection | Active comparator | Drug: intralesional steroidILCs group: 5 mg/mL every 4 weeks for 16 weeks |
Who may qualify
- Ages
- 18 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoflumilastPhosphodiesterase-4 (PDE4) inhibitor assigned to arm A | Drug | Arm A: 25 participants with AA will be on Roflumilast group |
| intralesional steroidintralesional injection of corticosteroid | Drug | 25 participants will receive intralesional steroid injection |
Primary outcome
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
To assess the degree of improvement in hair regrowth according to the change in SALT score from baseline to Week 16.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Yes. age, sex
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Roflumilast and intralesional steroid in people with Alopecia and Alopecia Areata, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.