A Phase I, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability Profile of Topical Cream SNG100 for 14 Days of Treatment in Moderate Atopic Dermatitis Subjects.
试验速览
- 阶段
- 1 期
- 入组人数
- 66
- 主要终点
- Side Effects AE's and SAE's
研究概览
简要总结
The investigators aimed to understand better the efficacy in a randomized, double-blind, intraindividual design trial in 66 participants with AD treated with SNG100, and 2 different strengths of topical steroids hydrocortisone and the medium potent mometasone furoate cream.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 6 years old or older with a diagnosis of moderate atopic dermatitis confirmed by a dermatologist
- •Any child age 6 to 18 with a diagnosis of moderate atopic dermatitis confirmed by a dermatologist, together with the child's parent/guardian. Written informed consent must be given by parent/guardian.
- •Capable of complying with study requirements and study procedure.
- •Investigator Global Assessment (IGA) of
- •The severity of atopic dermatitis will be defined as moderate by SCORAD range of 26-50 and EASI range of 7.1-21 points.
- •Child-bearing potential women must use a proper contraception method.
排除标准
- •As determined by the study doctor, a medical history that may interfere with study objectives.
- •Atopic dermatitis lesions that occur only on the face and scalp.
- •Presence of a secondary infection with bacteria, fungi, or virus.
- •Recent or current participation in another research study.
- •Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study.
- •Prior wound, tattoo, pigmentation or infection in the treated area.
研究组 & 干预措施
SNG100
Combination of low potency steroid with hydrating and moisturizing agents
干预措施: SNG100 (Drug)
Hydrocortisone
This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash).
干预措施: Hydrocortisone Acetate 1% Cream (Drug)
Mometasone furoate
This medication is used to treat skin conditions such as eczema, psoriasis, allergies, and rash.
干预措施: Mometasone Furoate (Drug)
结局指标
主要结局
Side Effects AE's and SAE's
时间窗: 4 weeks
Evaluate safety and tolerability as measured by completion of a full prescribed treatment course, treatment interruptions, SAE's and AE's
次要结局
- Usability(4 weeks)