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

Mayne Pharma

Status and phase

Completed

Phase 4

Conditions

Plaque Psoriasis

Treatments

Drug: Halobetasol Topical Foam

Study type

Interventional

Funder types

Industry

Identifiers

NCT03992261

122-0551-209

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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