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

Phase 2RecruitingNCT07297602

Nora Mohamed Abdelrazik36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Atopic Dermatitis

Interventions

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Baseline and Weeks 4, 8, and 12.

Secondary Outcomes

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.

Time frame: Throughout treatment; labs at baseline and monthly (Weeks 4, 8, 12).

Central Contacts

Nora Mohamed Abdelrazik, MD Dermatology

CONTACT

+201060291029 noraeldarawany@gmail.com

Ahmed Ibrahim Ali, Master degree of Dermatology