Efficacy and Tolerability of New Topical Formulations in Subjects With Atopic Dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- SCORAD (Severity Scoring of Atopic Dermatitis)
研究概览
简要总结
This is a 13 week randomized, double blind, parallel group, in home use study among approximately 60 male and female subjects, ages 12 to 65 years old inclusive, with atopic dermatitis (AD) SCORAD >16. Treatment group assignments will be balanced by disease severity, age, and body location of AD lesions. The study will consist of a 1 week washout phase and 12 week treatment phase. During the washout phase, subjects will be provided with a bar soap for bathing and showering and must refrain from using any other products on their body (excluding the face) including topical corticosteroids, ointments, lotions, sunscreens, etc. During the treatment phase, subjects will be randomized to 1 of 4 test legs. Throughout the treatment phase, the subjects will be required to use only the provided bar soap for bathing and showering and will apply their test product twice per day, once in the morning and once in the evening. No additional creams, moisturizers, lotions or cleansers other than those provided will be permitted for the duration of the study. Normal facial or hair care products are permitted, however, they must not contain anti-bacterial ingredients (e.g. antidandruff shampoo, acne products, etc).
SCORAD, EASI and PGA will incorporate whole body assessments. However, at the Baseline visit, subjects will have an active inflammatory lesion site and adjacent non-lesion, non-inflammatory site identified and marked for all instrumental and biopsy evaluations at Baseline and subsequent visits. Instrumental evaluations, imaging, expert visual grading and self-assessments will be performed throughout the study. Tolerability will be evaluated by incidence of AE's (defined per CTCAE), exacerbation of AD lesions, application site reactions/infections, and lab evaluations throughout the study. There will be additional consumption and compliance checks as well as dermatologic evaluations to ensure the subject's condition does not become extensively worse at each visit. A subset of subjects will have 2mm punch biopsies collected from the designated lesion and non-lesion sites at 3 time points throughout the study. The subset of subjects will be determined by subject willingness to participate in the biopsy portion as well as dermatologic evaluation and determination of biopsy candidacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a generally healthy, male or female, 12-65 years old, inclusive
- •Diagnosis of moderate or greater Atopic Dermatitis as determined by the Physician's Global Assessment (PGA of 3 or 4)
排除标准
- •Is currently participating or has participated in another interventional clinical study at this or any other facility in the past 2 weeks
- •Currently or has been diagnosed or treated for cancer in the past 5 years.
- •Requires any topical or systemic medications that could affect the course of their atopic dermatitis during the study period (except inhaled steroids and/or stable antihistamines for asthma or allergies).
- •Has a known hypersensitivity to any corticosteroid creams.
- •Has a known sensitivity to Epinephrine, Xylocaine or topical antibiotics.
- •Has a wound healing or blood-clotting abnormality.
- •Has any active infections or has used antibiotics in the past 7 days.
- •Has any physical attributes or skin conditions that might interfere with the clear visual or instrumental assessments.(i.e. cuts, sunburn, birth marks, tattoos, extensive scarring, excessive hair growth or acne)
- •Has an immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus rheumatoid arthritis) which could place the subject at risk or interfere with the accuracy of the study results.
- •Has used any immunosuppressant drugs or immunotherapy within the past 30 days or 5 half-lives.
- •Is an employee of the Sponsor Company or clinical testing site.
- •Is diabetic.
- •Is dependent on oral medication for any skin disease/condition or could not, in the opinion of the Investigator tolerate the restriction of discontinuing the medicine as required in this study.
- •Is currently pregnant or lactating or planning to become pregnant in the next 6 months.
- •Has a history of keloid formation following skin injury.
- •Is routinely taking anti-coagulant medications (i.e. Plavix, Coumadin, warfarin, heparin, etc.)
- •Any other condition or factor the Investigator or their duly assigned representative believes may affect the ability of the subject to complete the study or the interpretation of the results.
研究组 & 干预措施
Investigational OTC Cream
Investigational OTC Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and anywhere else the patient would apply their ordinary body moisturizer.
干预措施: Investigational OTC Cream (Drug)
Placebo Cream
Placebo Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and anywhere else the patient would apply their ordinary body moisturizer.
干预措施: Placebo Cream (Other)
Cosmetic Eczema Cream
Cosmetic Eczema Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and anywhere else the patient would apply their ordinary body moisturizer.
干预措施: Cosmetic Eczema Cream (Other)
0.05% Desonide Cream
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 4 weeks to atopic dermatitis lesions and then on any new lesions that appear for 4 weeks and as directed by the study doctor.
Placebo Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, anywhere the patient would apply their ordinary body moisturizer except atopic dermatitis lesions.
干预措施: 0.05% Desonide Cream (Drug)
0.05% Desonide Cream
Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 4 weeks to atopic dermatitis lesions and then on any new lesions that appear for 4 weeks and as directed by the study doctor.
Placebo Cream applied topically, twice daily, for 12 weeks, once in the morning and once in the evening, anywhere the patient would apply their ordinary body moisturizer except atopic dermatitis lesions.
干预措施: Placebo Cream (Other)
结局指标
主要结局
SCORAD (Severity Scoring of Atopic Dermatitis)
时间窗: Change from Baseline at Week 12
Dermatologic assessment and scoring of atopic dermatitis lesion severity
次要结局
- SCORAD (Severity Scoring of Atopic Dermatitis)(Change from Baseline at Week 8)