Overview

Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis

Status:
Terminated
Trial end date:
2020-07-28
Target enrollment:
Participant gender:
Summary
Open-Label Study designed to evaluate the HPA axis suppression potential of Clobetasol Topical Oil and pharmacokinetic safety / systemic exposure to clobetasol when Clobetasol Topical Oil is applied to pediatric subjects with moderate to severe atopic dermatitis (AD) under maximal use conditions. The study duration for each subject will be up to 54 days (up to 38 days for Screening assessments, followed by up to 16 days of treatment and follow-up). Additional time will be required for subjects requiring additional hypothalamic-pituitary-adrenal [HPA] axis function testing due to an abnormal result at End of Treatment.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Hill Dermaceuticals, Inc.
Collaborators:
Covance
Synteract, Inc.
Treatments:
Clobetasol