NCT03847389

Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis

Open-Label Study of the Pharmacokinetics and Safety Including HPA Axis Suppression Potential of Clobetasol Topical Oil in Pediatric Subjects With Moderate to Severe Atopic Dermatitis

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Hill Dermaceuticals, Inc. · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a multicenter, open-label study designed to evaluate the HPA axis suppression potential and systemic exposure to clobetasol, when administered as Clobetasol Topical Oil in pediatric subjects, under conditions consistent with anticipated clinical use and under conditions designed to maximize the potential for drug absorption in subjects with moderate to severe AD. The study will consist of three successively younger pediatric cohorts, as safety data allow: * Cohort 1: ≥12 to \<18 years; * Cohort 2: ≥6 to \<12 years; and * Cohort 3: ≥2 to \<6 years. Enrollment into each successively younger pediatric cohort will proceed only after the preceding cohort has been completed and safety and exploratory data (including adverse events \[AEs\], tolerability assessments, clinical laboratory results, and the percentage of subjects with HPA axis suppression) have been reviewed and agreed to be acceptable for progression to the next cohort. Enrollment into Cohorts 2 and 3 will proceed only if the percentage of subjects with HPA axis suppression in Cohorts 1 and 2, respectively, is ≤40%. HPA axis suppression is defined as a cortisol concentration ≤18 µg/100 mL at approximately 30 minutes after stimulation with cosyntropin.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Clobetasol propionate 0.05% Topical Oil	thin film application of the oil twice daily

Timeline

• Start date: 2019-09-09
• Primary completion: 2020-05-02
• Completion: 2020-07-28
• First posted: 2019-02-20
• Last updated: 2021-06-23
• Results posted: 2021-06-23

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study