Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis

NCT03992261 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-07-06

Study results available
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Summary

The purpose of this study is to evaluate Halobetasol Propionate (HBP) foam, 0.05% in subjects aged 12 through less than 18 years with plaque psoriasis in order to check the safety, the potential to suppress the adrenal glands and the degree to which the drug is absorbed into the bloodstream.

Conditions

Interventions

DRUG

Halobetasol Topical Foam

Foam

Sponsors & Collaborators

  • Mayne Pharma International Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Daniel J Piacquadio, MD · Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-14
Primary Completion
2019-12-30
Completion
2019-12-30
FDA Drug
Yes

Countries

  • United States
  • Georgia
  • Poland
  • Ukraine

Study Locations

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Entities

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 NCT03992261 on ClinicalTrials.gov