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Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis

NCT03847389 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-06-23

Study results available
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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.

Conditions

Interventions

DRUG

Clobetasol propionate 0.05% Topical Oil

thin film application of the oil twice daily

Sponsors & Collaborators

  • Synteract, Inc.

    collaborator INDUSTRY

  • Covance

    collaborator INDUSTRY

  • Hill Dermaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Rosario G Ramirez, MD · Hill Dermaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-09
Primary Completion
2020-05-02
Completion
2020-07-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03847389 on ClinicalTrials.gov