Evaluation of Efficacy and Safety of Oral Roflumilast in Treatment of Moderate to Severe Atopic Dermatitis: a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The primary outcome of the study is the change in the SCORAD Index from baseline to the end of treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Oral roflumilast (Drug)
结局指标
主要结局
The primary outcome of the study is the change in the SCORAD Index from baseline to the end of treatment
时间窗: 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.
次要结局
- Safety - incidence of treatment-emergent adverse events and laboratory abnormalities.(Throughout treatment; labs at baseline and monthly (Weeks 4, 8, 12).)
研究者
Nora Mohamed Abdelrazik
Lecturer of Dermatology
Mansoura University Hospital