A Randomized, Double-Blind, Placebo-controlled, Three-arm, Parallel Assignment, Multi-centre, Therapeutic Equivalence Study of Two Tacrolimus 0.1% Topical Ointment Formulations in Adult Patients with Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 650
- 试验地点
- 9
- 主要终点
- Change from baseline in Eczema Area and Severity Index (EASI) score
研究概览
简要总结
A Randomized, Double-Blind, Placebo-controlled,Three-arm, Parallel Assignment,Multi-centre, Therapeutic Equivalence Study of Two Tacrolimus 0.1% Topical Ointment Formulations in Adult Patientswith Moderate to Severe Atopic Dermatitis
Atopic dermatitis (AD) is an inflammatory skindisease with a chronically relapsing course and is characterized by episodes ofintense pruritus, lichenification, severely dry skin, and a susceptibility tocutaneous infections. [1-4] Atopic dermatitis impacts the quality oflife (QOL) of patients physically (itch, pain), psychologically (such ashindrance of social interaction, low self-esteem, and sleep disturbance) andfinancially.
AD, a common skin disease that occurs in persons ofall ages, whose prevalence worldwide hasincreased two- to threefold over the last 50 years. For almost half a century,conventional management of AD has been based on the use of emollients toalleviate dry skin, coupled with short courses of topical corticosteroids totreat flares. Topical corticosteroids have long been the first-line treatmentfor AD. Although the efficacy of topical corticosteroids in controlling acutesymptoms of AD is well established in the short term with good tolerability ingeneral, potential side effects limit their use in the long-term.
Inclusion criteria
1. Maleor non-pregnant, non-lactating female of any ethnic group, 18 – 70 years of age(both inclusive) at the time of signing the informed consent.
2. Patients having atopic dermatitis according toHanifin and Rajka diagnostic criteria (AppendixI).
3. Patients with a grading of moderate to severe AD (i.e.a score of at least 4.5) as defined by the scoring system of Rajka andLangeland (Appendix II).
Non-immunocompromised adults who have failed torespond adequately to other topical prescription treatments for AD, or whenthose treatments are not advisable in the opinion of the InvestigatorExclusion criteria
1. Newly diagnosed or Treatment naïve patients.
2. Patients with mild (Rajka and Langeland score of <4.5) or very severe atopic dermatitis that requires systemic therapy.
3. Patients in need of undergoing UV treatments for AD.
4. Clinically infected atopic dermatitis at the baselinevisit.
5. Anydeermatological condition other than atopic dermatitis asscar/wound/tattoo at the application site or in its close vicinity that in the Investigator’sopinion may interfere with the evaluation of the patient’s atopic dermatitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or non-pregnant, non-lactating female of any ethnic group, 18 – 70 years of age (both inclusive) at the time of signing the informed consent.
- •2.Patients having atopic dermatitis according to Hanifin and Rajka diagnostic criteria (Appendix I).
- •3.Patients with a grading of moderate to severe AD (i.e. a score of at least 4.5) as defined by the scoring system of Rajka and Langeland (Appendix II).
- •4.Non-immunocompromised adults who have failed to respond adequately to other topical prescription treatments for AD, or when those treatments are not advisable in the opinion of the Investigator.
- •5.Last application of medicated topical agents, intake of systemic antihistamines, intranasal or inhaled corticosteroids (> 1 mg/day) should be minimum 7 days prior to randomization.
- •6.Last application of tacrolimus ointment, intake of systemic corticosteroids and nonsteroidal immunosuppressants should be minimum 3 weeks prior to randomization.
排除标准
- •1.Newly diagnosed or Treatment naïve patients 2.Patients with mild (Rajka and Langeland score of < 4.5) or very severe atopic dermatitis that requires systemic therapy 1.Patients in need of undergoing UV treatments for AD.
- •2.Clinically infected atopic dermatitis at the baseline visit.
结局指标
主要结局
Change from baseline in Eczema Area and Severity Index (EASI) score
时间窗: Day 0, Day 4. day 7, day 14, day 21, Day 28, day 28, day 42 and day 56
次要结局
- 4.Physician’s Assessment of Individual Signs of Atopic Dermatitis(Week 6 / End of Treatment (EOT) Visit)
- 1.Percentage of patients with ≥ 60% improvement on EASI total score(Week 6 / End of Treatment (EOT) Visit)
- 3. Percentage of body surface area affected (% BSA affected)(Week 6 / End of Treatment (EOT) Visit)
- 2.Change in grading of AD as defined by the scoring system of Rajka and Langeland from baseline(at Week 6 / End of Treatment (EOT) Visit)
- 5.Patient’s Assessment of Pruritus(week 6/ End of Treatment (EOT))