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

Plaque Psoriasis Clinical Trial

Official title:

Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily Halobetasol Propionate Foam, 0.05% in Subjects 12 to Less Than 18 Years of Age With Plaque Psoriasis Receiving Two Weeks of Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03992261
• Other study ID #: 122-0551-209
• Status: Completed
• Phase: Phase 4
• Start date: June 14, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: March 2023
• Source: Mayne Pharma International Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• Halobetasol Topical Foam
Foam

Locations

Country	Name	City	State
Georgia	Investigative Site 9	Batumi
Georgia	Investigative Site 10	Tbilisi
Georgia	Investigative Site 11	Tbilisi
Poland	Investigative Site 3	Krakow
Poland	Investigative Site 5	Tarnów
Poland	Investigative Site 4	Warszawa
Ukraine	Investigative Site 8	Rivne
Ukraine	Investigative Site 6	Uzhhorod
Ukraine	Investigative Site 7	Zaporizhzhya
United States	Investigative Site 2	Hialeah	Florida
United States	Investigative Site 1	Saint Joseph	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Mayne Pharma International Pty Ltd

Countries where clinical trial is conducted

United States,  Georgia,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects to Exhibit Adrenal Suppression as Measured by a Cosyntropin Stimulation Test	A subject is considered to have adrenal suppression evidence if post cosyntropin stimulation lab draw result is less than or equal to 18.0 mcg/100 mL.; HPA axis responses to cosyntropin were dichotomized to normal and abnormal. Cosyntropin stimulation testing was performed at Screening and Day 15 and approximately 4 weeks post-treatment if a subject's laboratory results at Day 15 showed an abnormal hypothalamic pituitary adrenal (HPA) axis response (HPA axis suppression). An abnormal HPA axis response was defined as a 30-minute post-stimulation serum cortisol level of =18 µg/dL at end of study (EOS).	Screening, Day 15, and approximately 4 weeks post-treatment, an average of 28 days
Primary	Plasma Concentration of HBP at Screening, Day 8 and Day 15	Morning trough concentrations of HBP in plasma at Screening, Day 8, and Day 15 were summarized for the PK population using geometric mean, coefficient of variation in addition to n, mean, median, standard deviation (SD), minimum, and maximum.	15 days