Safety, Tolerability and Efficacy of ZEP-3Na (0.1% or 1%) Compared to Placebo in Subjects With Mild to Moderate Atopic Dermatitis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Atopic Dermatitis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 5 years and 75 years
- Gender
- Both males and females
Description
165 subjects, 5-75 years old with mild to moderate Atopic Dermatitis will be enrolled to the study. The investigational product which is the synthetic analogue of the natural compound found in the rattle snake venom will be administered topically twice daily. The duration of the study will be up to ...
165 subjects, 5-75 years old with mild to moderate Atopic Dermatitis will be enrolled to the study. The investigational product which is the synthetic analogue of the natural compound found in the rattle snake venom will be administered topically twice daily. The duration of the study will be up to 17 weeks consisting of up to 3 weeks of screening, 12 weeks of treatment, followed by 2 weeks of follow-up. Efficacy will be measured by IGA (Investigator Global Assessment, EASI (Eczema Area and Severity Index) and SCORAD (SCORing Atopic Dermatitis). Lesions will be photographed throughout the study. Physical examination and vital signs will be measured during every visit. Patients will complete quality of life questionnaires, itching scale and diaries.
Tracking Information
- NCT #
- NCT04307862
- Collaborators
- Not Provided
- Investigators
- Not Provided
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