Atopic DermatitisPhase 2ROFLU-AD12NCT07297602
Evaluation of Efficacy and Safety of Oral Roflumilast for Treatment of Moderate to Severe Atopic Dermatitis in Patients Aged 12 Years and Older: A Pilot Study
A Phase 2 study testing Oral roflumilast in people with Atopic Dermatitis, run by Nora Mohamed Abdelrazik at 1 site in Egypt.
Trial summary
This is a 12-week, single-arm, open-label pilot study to assess the safety and preliminary efficacy of oral roflumilast in patients aged 12 years and older with moderate-to-severe atopic dermatitis All participants, both male and female, will receive oral roflumilast starting at 250 mcg once daily for 10 days… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Oral roflumilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Nov 2025to 20 May 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- AD patients ≥ 12 years in whom systemic therapy is indicated.
- Patients who don't use other systemic therapy for AD in the last 2 months (or naïve who didn't use any systemic therapy before).
- Safe contraception during the study.
Who cannot join
- Pregnant or lactating women, as well as women of childbearing potential not using an effective method of contraception.
- Age <12 years.
- Other concomitant AD systemic treatments such as cyclosporins and biologics.
- Previous systemic treatment of AD in the last 2 months.
- Patients receiving inducers or inhibitors of cytochromes CYP3A4 and CYP1A.
- Other systemic diseases other than COPD, especially hepatic impairment.
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- Hypersensitivity to the active substance of roflumilast or to any of its excipients.
- The use of contraception with gestodene and ethinylestradiol.
- Unreliable patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed Ibrahim Ali, Master degree of Dermatology contact
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35511
Sara Hamdy Fouad, MD Dermatology, +201003486001, sara_hamdy@mans.edu.eg
About this study
Official title: Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Atopic Dermatitis: a Pilot Study
This is a 12-week, single-arm, open-label pilot study to assess the safety and preliminary efficacy of oral roflumilast in patients aged 12 years and older with moderate-to-severe atopic dermatitis All participants, both male and female, will receive oral roflumilast starting at 250 mcg once daily for 10 days, followed by 500 mcg once daily for the remainder of the study. The primary outcome is the mean change in SCORAD (Scoring Atopic Dermatitis) score from baseline to Week 12. Secondary outcome include safety assessments, including treatment-emergent adverse events, serious adverse events, and laboratory abnormalities. Male and female participants will be analyzed as subgroups to explore potential differences in response or safety.
- Conditions
- Atopic Dermatitis
- Being tested
- Oral roflumilast
- Keywords
- Atopic dermatitis, Oral roflumilast, Moderate-to-severe AD, Efficacy, Safety, Adolescents and Adults
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral roflumilastDrug
Also called Roflumilast (generic name), Daxas (brand name in some countries), Roflumilast 500 mcg tablet (formulation identifier)
Participants will receive oral roflumilast. The initial dose is 250 mcg once daily for the first 10 days, followed by a dose escalation to 500 mcg once daily for the remainder of the 12-week treatment period.
Route: Oral Schedule: Daily for 12 weeks Duration: 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Evaluation of Oral Roflumilast in Moderate to Severe Atopic Dermatitis | Experimental | All participants, both male and female, will receive oral roflumilast. No placebo or comparator is included. Male and female participants will be analyzed as subgroups for exploratory safety and efficacy outcomes. Receives: Drug: Oral roflumilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the study is the change in the SCORAD Index from baseline to the end of treatment
SCORAD is a validated scoring system that provides a comprehensive assessment of atopic dermatitis by combining:
Extent of eczema: The percentage of total body surface area affected (0-100%), assessed using standard dermatologic mapping.
Intensity of clinical signs: Six features-erythema, swelling ,oozing/crusts, scratch marks, lichenification, and dryness-each graded from 0 (absent) to 3 (severe).
Patient-reported symptoms: Daily pruritus (itch) and sleep disturbance, each rated on a 0-10 visual analogue scale.
The total SCORAD score ranges from 0 to 103, with higher values indicating more severe disease.
Changes in SCORAD are reported as:
Absolute reduction, and
Percentage improvement from baseline (e.g., SCORAD-50 or SCORAD-75).
This outcome measure captures both objective clinical improvement and patient-experienced symptom relief, providing a holistic evaluation of treatment efficacy.
Measured: Baseline and Weeks 4, 8, and 12.
Secondary outcomes (1)
Safety - incidence of treatment-emergent adverse events and laboratory abnormalities.
Incidence and severity of adverse events (including diarrhea, nausea, abdominal pain, weight loss, decreased appetite, insomnia, headache) and clinically significant changes in CBC, hepatic profile, and serum creatinine.
Measured: Throughout treatment; labs at baseline and monthly (Weeks 4, 8, 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start20 Nov 2025
- Primary completion20 May 2026 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label pilot study in which all participants, both male and female, receive oral roflumilast. Participants will not be randomized to different treatments. Male and female participants will be analyzed as subgroups to explore potential sex-based differences in safety and efficacy. No placebo or comparator group is included.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nora Mohamed Abdelrazik
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University Hospital
- Responsible party
- Sponsor-investigator, Nora Mohamed Abdelrazik, Mansoura University Hospital
- Investigators
- Abeer Mohamed Elkholy, MD Dermatology, Study chair, Faculty of medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07297602
- Sponsor's protocol ID
- R.25.11.3442.R1
- Acronym
- ROFLU-AD12
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Atopic Dermatitis: a Pilot Study
- ClinicalTrials.gov ID
- NCT07297602
- Acronym / sponsor ID
- ROFLU-AD12 / R.25.11.3442.R1
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Oral roflumilast, Moderate-to-severe AD, Efficacy, Safety, Adolescents and Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Nora Mohamed AbdelrazikUniversity, hospital or other
- Collaborators
- Mansoura University Hospital
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 22 Dec 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.
This is a 12-week, single-arm, open-label pilot study to assess the safety and preliminary efficacy of oral roflumilast in patients aged 12 years and older with moderate-to-severe atopic dermatitis All participants, both male and female, will receive oral roflumilast starting at 250 mcg once daily for 10 days, followed by 500 mcg once daily for the remainder of the study. The primary outcome is the mean change in SCORAD (Scoring Atopic Dermatitis) score from baseline to Week 12. Secondary outcome include safety assessments, including treatment-emergent adverse events, serious adverse events, and laboratory abnormalities. Male and female participants will be analyzed as subgroups to explore potential differences in response or safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label pilot study in which all participants, both male and female, receive oral roflumilast. Participants will not be randomized to different treatments. Male and female participants will be analyzed as subgroups to explore potential sex-based differences in safety and efficacy. No placebo or comparator group is included.
| Arm | Type | Receives |
|---|---|---|
| Evaluation of Oral Roflumilast in Moderate to Severe Atopic Dermatitis | Experimental | Drug: Oral roflumilastAll participants, both male and female, will receive oral roflumilast. No placebo or comparator is included. Male and female participants will be analyzed as subgroups for exploratory safety and efficacy outcomes. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- AD patients ≥ 12 years in whom systemic therapy is indicated.
- Patients who don't use other systemic therapy for AD in the last 2 months (or naïve who didn't use any systemic therapy before).
- Safe contraception during the study.
Key exclusion criteria (9 listed)
- Pregnant or lactating women, as well as women of childbearing potential not using an effective method of contraception.
- Age <12 years.
- Other concomitant AD systemic treatments such as cyclosporins and biologics.
- Previous systemic treatment of AD in the last 2 months.
- Patients receiving inducers or inhibitors of cytochromes CYP3A4 and CYP1A.
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 |
|---|---|---|
| Oral roflumilastAlso: Roflumilast (generic name), Daxas (brand name in some countries), Roflumilast 500 mcg tablet (formulation identifier)Participants will receive oral roflumilast. The initial dose is 250 mcg once daily for the first 10 days, followed by a dose escalation to 500 mcg once daily for the remainder of the 12-week treatment period. Route: Oral Schedule: Daily for 12 weeks Duration: 12 weeks | Drug | Evaluation of Oral Roflumilast in Moderate to Severe Atopic Dermatitis |
Primary outcome
The primary outcome of the study is the change in the SCORAD Index from baseline to the end of treatment
Time frame: Baseline and Weeks 4, 8, and 12.
SCORAD is a validated scoring system that provides a comprehensive assessment of atopic dermatitis by combining: Extent of eczema: The percentage of total body surface area affected (0-100%), assessed using standard dermatologic mapping. Intensity of clinical signs: Six features-erythema, swelling ,oozing/crusts, scratch marks, lichenification, and dryness-each graded from 0 (absent) to 3 (severe). Patient-reported symptoms: Daily pruritus (itch) and sleep disturbance, each rated on a 0-10 visual analogue scale. The total SCORAD score ranges from 0 to 103, with higher values indicating more severe disease. Changes in SCORAD are reported as: Absolute reduction, and Percentage improvement from baseline (e.g., SCORAD-50 or SCORAD-75). This outcome measure captures both objective clinical improvement and patient-experienced symptom relief, providing a holistic evaluation of treatment efficacy.
1 secondary outcome
Safety - incidence of treatment-emergent adverse events and laboratory abnormalities.
Time frame: Throughout treatment; labs at baseline and monthly (Weeks 4, 8, 12).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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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.
Ahmed Ibrahim Ali, Master degree of Dermatology contact
Abeer Mohamed Elkholy, MD Dermatology study chair
Faculty of medicine, Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral roflumilast in people with Atopic Dermatitis, run by Nora Mohamed Abdelrazik 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 30 Dec 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nora Mohamed Abdelrazik, MD Dermatology (+201060291029, noraeldarawany@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome of the study is the change in the SCORAD Index from baseline to the end of treatment (time frame: Baseline and Weeks 4, 8, and 12.). 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 30 Dec 2025.