MedDataX Logo

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

NCT ID: NCT07297602

Last Updated: 2025-12-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-05-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atopic Dermatitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Atopic dermatitis Oral roflumilast Moderate-to-severe AD Efficacy Safety Adolescents and Adults

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label study: neither the participants nor the investigators are blinded. All participants receive oral roflumilast, and both participants and study staff are aware of the treatment assignment. No placebo or comparator is used.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Evaluation of Oral Roflumilast in Moderate to Severe Atopic Dermatitis

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.

Group Type EXPERIMENTAL

Oral roflumilast

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral roflumilast

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Roflumilast (generic name) Daxas (brand name in some countries) Roflumilast 500 mcg tablet (formulation identifier)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* Hypersensitivity to the active substance of roflumilast or to any of its excipients.
* The use of contraception with gestodene and ethinylestradiol.
* Unreliable patients.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mansoura University Hospital

OTHER

Sponsor Role collaborator

Nora Mohamed Abdelrazik

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nora Mohamed Abdelrazik

Lecturer of Dermatology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Abeer Mohamed Elkholy, MD Dermatology

Role: STUDY_CHAIR

Faculty of medicine, Mansoura University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nora Mohamed Abdelrazik, MD Dermatology

Role: CONTACT

Phone: +201060291029

Email: [email protected]

Ahmed Ibrahim Ali, Master degree of Dermatology

Role: CONTACT

Phone: +201011442104

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sara Hamdy Fouad, MD Dermatology

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R.25.11.3442.R1

Identifier Type: -

Identifier Source: org_study_id