Trial Outcomes & Findings for Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis (NCT NCT03992261)

Last Updated: 2023-07-06

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

Screening, Day 15, and approximately 4 weeks post-treatment, an average of 28 days

Results posted on

2023-07-06

Participant Flow

Participant milestones

Participant milestones
Measure	Halobetasol Propionate Foam, 0.05% 24 subjects with stable plaque psoriasis on at least 10% body surface area (BSA) (excluding: face, scalp, groin, axillae, and other intertriginous areas), who fulfilled the inclusion/exclusion criteria were enrolled at multiple study sites in the US and Europe. All subjects were to have a Cosyntropin Stimulation Test (CST) to assess their hypothalamic pituitary adrenal (HPA) axis response at Visit 1/Screening initiated between 7 and 9 AM. Enrollment into the treatment phase of the study should have been timed such that the Screening CST was performed a minimum of 20 days before Visit 2/Baseline. At Visit 2/Baseline, eligible subjects with normal adrenal function were eligible to participate in the study. Subjects were instructed to apply Halobetasol Propionate (HBP) Foam, 0.05% to all psoriasis plaques identified at Visit 2/Baseline twice daily (approximately every 12 hours) for the assigned treatment period or until the investigator verified the subject's psoriasis had cleared.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Halobetasol Propionate Foam n=24 Participants Open label evaluation all participants received Halobetasol Propionate Foam, 0.05% 2 times daily for 2 weeks of application in subjects 12-17 years of age
Age, Categorical <=18 years	24 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening, Day 15, and approximately 4 weeks post-treatment, an average of 28 days

Population: Evaluable subjects

Outcome measures

Outcome measures
Measure	Halobetasol Propionate Foam n=23 Participants 2 weeks of application, 2 times daily Halobetasol Topical Foam: Foam
Number of Subjects to Exhibit Adrenal Suppression as Measured by a Cosyntropin Stimulation Test Abnormal HPA Axis Response	6 Participants
Number of Subjects to Exhibit Adrenal Suppression as Measured by a Cosyntropin Stimulation Test Normal HPA Axis Response	17 Participants

PRIMARY outcome

Timeframe: 15 days

Population: Pharmacokinetic Population

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.

Outcome measures

Outcome measures
Measure	Halobetasol Propionate Foam n=23 Participants 2 weeks of application, 2 times daily Halobetasol Topical Foam: Foam
Plasma Concentration of HBP at Screening, Day 8 and Day 15 Baseline number of participants with plasma morning trough concentrations below limits	23 Participants
Plasma Concentration of HBP at Screening, Day 8 and Day 15 Day 8 number of participants with plasma morning trough concentrations below limits	14 Participants
Plasma Concentration of HBP at Screening, Day 8 and Day 15 Day 15/EOS number of participants with plasma morning trough concentrations below limits	13 Participants
Plasma Concentration of HBP at Screening, Day 8 and Day 15 Day 8 Subjects with measurable levels of HBP at morning trough	9 Participants
Plasma Concentration of HBP at Screening, Day 8 and Day 15 Day 15/EOS Subjects with measurable levels of HBP at morning trough	6 Participants

Adverse Events

Halobetasol Propionate Foam, 0.05%

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Halobetasol Propionate Foam, 0.05% n=24 participants at risk 24 subjects with stable plaque psoriasis on at least 10% BSA (excluding: face, scalp, groin, axillae, and other intertriginous areas), who fulfilled the inclusion/exclusion criteria were enrolled at multiple study sites in the US and Europe. All subjects were to have a Cosyntropin Stimulation Test (CST) to assess their HPA axis response at Visit 1/Screening initiated between 7 and 9 AM. Enrollment into the treatment phase of the study should have been timed such that the Screening CST was performed a minimum of 20 days before Visit 2/Baseline. At Visit 2/Baseline, eligible subjects with normal adrenal function were eligible to participate in the study. Subjects were instructed to apply HBP Foam, 0.05% to all psoriasis plaques identified at Visit 2/Baseline twice daily (approximately every 12 hours) for the assigned treatment period or until the investigator verified the subject's psoriasis had cleared.
Skin and subcutaneous tissue disorders Local skin reactions	25.0% 6/24 • Number of events 6 • Collected at study visits, days 1, 8, and 15. In accordance with standard MedDRA reporting requirements.
Endocrine disorders ACTH Stimulation Test Abnormal	29.2% 7/24 • Number of events 8 • Collected at study visits, days 1, 8, and 15. In accordance with standard MedDRA reporting requirements.

Additional Information

Lee Ann McDowell, PharmD - Director of Medical Affairs

Mayne Pharma

Phone: 4124776681

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place