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

NCT ID: NCT03992261

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-14
• Study Completion Date: 2019-12-30

Brief 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.

Detailed Description

This is a Phase 4 (for US site only, Phase 2 for non-US sites), open label, multicenter study of halobetasol propionate (HBP) Foam, 0.05% in male and female subjects who are 12 to less than 18 years of age with stable plaque psoriasis. Twenty-four subjects with stable plaque psoriasis on at least 10% of their body surface area (BSA) (excluding the face, scalp, groin, axillae, and other intertriginous areas), who fulfill the inclusion/exclusion criteria will be enrolled at multiple study sites in the US and Europe. All subjects are to have a Cosyntropin Stimulation Test (CST) to assess their (hypothalmic pituitary adrenal) HPA axis response at Visit 1/Screening initiated between 7 and 9 AM. Enrollment into the treatment phase of the study will be timed such that the Screening CST is performed a minimum of 20 days before Visit 2/Baseline. At Visit 2/Baseline, eligible subjects with normal adrenal function will be eligible to participate in the study.

The primary objective of the study is to assess safety, not efficacy. Safety will be determined by assessing the adrenal suppression potential and the PK properties of HBP Foam, 0.05% applied twice daily in male and female subjects who were 12 to less than 18 years of age with stable plaque psoriasis.

Other safety endpoints include plasma levels of HBP. Trough HBP concentrations in plasma on day 8 and 15 will be calculated and summarized. Efficacy will also be noted utilizing the Investigator's Global Assessment (IGA) scale and percent BSA treated and affected with disease to assess and document any changes observed with regard to IGA and percent BSA.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Halobetasol Propionate Foam

2 weeks of application, 2 times daily

Group Type: EXPERIMENTAL

Halobetasol Topical Foam

Intervention Type: DRUG

Foam

Interventions

Halobetasol Topical Foam

Foam

Intervention Type: DRUG

Other Intervention Names

HBP Foam

Eligibility Criteria

Inclusion Criteria

• Subject is male or non-pregnant female and is 12 to less than 18 years of age
• Subject has provided written informed assent and was accompanied by the parent or legal guardian at the time of assent/consent signing
• Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10% Body Surface Area (BSA)
• Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit

Exclusion Criteria

• Subject has spontaneously improving or rapidly deteriorating plaque psoriasis
• Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
• Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function or which exposes the subject to an unacceptable risk by study participation
• Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation
• Subject is pregnant, lactating, or is planning to become pregnant during the study
• Subject is currently enrolled in an investigational drug or device study

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayne Pharma International Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel J Piacquadio, MD

Role: STUDY_DIRECTOR

Therapeutics, Inc.

Locations

Investigative Site 2

Hialeah, Florida, United States

Investigative Site 1

Saint Joseph, Missouri, United States

Investigative Site 9

Batumi, , Georgia

Investigative Site 10

Tbilisi, , Georgia

Investigative Site 11

Tbilisi, , Georgia

Investigative Site 3

Krakow, , Poland

Investigative Site 5

Tarnów, , Poland

Investigative Site 4

Warsaw, , Poland

Investigative Site 8

Rivne, , Ukraine

Investigative Site 6

Uzhhorod, , Ukraine

Investigative Site 7

Zaporizhzhya, , Ukraine

Countries

United States; Georgia; Poland; Ukraine

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

122-0551-209

Identifier Type: -

Identifier Source: org_study_id