Trial Outcomes & Findings for Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis (NCT NCT02340169)

Last Updated: 2023-03-28

Results Overview

A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria: * their 30 minute post injection cortisol level is not at least 7 mcg/100 ml greater than the basal level (\< basal + 7) * the post stimulation level is ≤ 18 mcg/100 ml

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

129 participants

Primary outcome timeframe

28 days

Results posted on

2023-03-28

Participant Flow

The first patient enrolled in the study 23 January 2015. The last patient completed the study 22 November 2019. The Patients were enrolled in 3 cohorts. Cohort 1, 12 to 17 years and 11 months, Cohort 2, 6 year to 11 and 11 Months and Cohort 3, 2 years to 5 years and 11 months. In total 129 subjects were enrolled across 7 Investigator sites.

Prior to the Protocol Amendment if a subject was found to have an abnormal adrenal function test after the baseline Cortisol Response test the subject was notified to discontinue the drug and follow up with the Investigator. After the protocol amendment a screening visit was added so that subjects with abnormal tests would not be randomized to study drug.

Participant milestones

Participant milestones
Measure	Topicort® Topical Spray, 0.25% Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days Topicort® (desoximetasone) Topical Spray, 0.25%: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
Overall Study STARTED	129
Overall Study Cohort 1 12-17 Years of Age	84
Overall Study Cohort 2 6 to 11 Years of Age	35
Overall Study Cohort 3 2 to 5 Years of Age	10
Overall Study COMPLETED	106
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

the participants were analyzed in three separate cohorts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Topicort® Topical Spray, 0.25% n=129 Participants Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days Topicort® (desoximetasone) Topical Spray, 0.25%: Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
Age, Customized Cohort 1 - 12 to 17 years of age	84 Participants n=129 Participants
Age, Customized Cohort 2- 6 to 11 years of age	35 Participants n=129 Participants
Age, Customized Cohort 3 - 2 to 5 years of age	10 Participants n=129 Participants
Sex: Female, Male Cohort 1 -12 to 17 years of age · Female	35 Participants n=84 Participants • the participants were analyzed in three separate cohorts
Sex: Female, Male Cohort 1 -12 to 17 years of age · Male	49 Participants n=84 Participants • the participants were analyzed in three separate cohorts
Sex: Female, Male Cohort 2 - 6 to 11 years of age · Female	23 Participants n=35 Participants • the participants were analyzed in three separate cohorts
Sex: Female, Male Cohort 2 - 6 to 11 years of age · Male	12 Participants n=35 Participants • the participants were analyzed in three separate cohorts
Sex: Female, Male Cohort 3- 2 to 5 years of age · Female	4 Participants n=10 Participants • the participants were analyzed in three separate cohorts
Sex: Female, Male Cohort 3- 2 to 5 years of age · Male	6 Participants n=10 Participants • the participants were analyzed in three separate cohorts
Ethnicity (NIH/OMB) Hispanic or Latino	126 Participants n=129 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=129 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=129 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=129 Participants
Race (NIH/OMB) Asian	0 Participants n=129 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=129 Participants
Race (NIH/OMB) Black or African American	1 Participants n=129 Participants
Race (NIH/OMB) White	102 Participants n=129 Participants
Race (NIH/OMB) More than one race	0 Participants n=129 Participants
Race (NIH/OMB) Unknown or Not Reported	26 Participants n=129 Participants
Region of Enrollment United States	76 participants n=129 Participants
Region of Enrollment Panama	27 participants n=129 Participants
Region of Enrollment El Salvador	26 participants n=129 Participants
Hypothalamic-Pituitary-Adrenal (HPA) Axis Function Cohort 1 - 12 to 17 years of age	60 Participants n=84 Participants • HPA Axis suppression was measured in the 100 evaluable subjects.
Hypothalamic-Pituitary-Adrenal (HPA) Axis Function Cohort 2 - 6 to 11 years of age	30 Participants n=35 Participants • HPA Axis suppression was measured in the 100 evaluable subjects.
Hypothalamic-Pituitary-Adrenal (HPA) Axis Function Cohort 3 - 2 to 5 years of age	10 Participants n=10 Participants • HPA Axis suppression was measured in the 100 evaluable subjects.

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	Cohort 1 n=60 Participants 12 to 17 Years of Age	Cohort 2 n=30 Participants 6 to 11 Years of age	Cohort 3 n=10 Participants 2 to 5 years of age
The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test	21 Participants	13 Participants	2 Participants

SECONDARY outcome

Timeframe: 28 days

The total number of subjects experiencing adverse events.

Outcome measures

Outcome measures
Measure	Cohort 1 n=129 Participants 12 to 17 Years of Age	Cohort 2 6 to 11 Years of age	Cohort 3 2 to 5 years of age
Adverse Event	1 Participants	—	—

SECONDARY outcome

Timeframe: 28 Days

Population: PK sampling from was taken from a subset of patients in cohorts 1 and 2

Concentration prior to dosing at steady state.

Outcome measures

Outcome measures
Measure	Cohort 1 n=11 Participants 12 to 17 Years of Age	Cohort 2 n=8 Participants 6 to 11 Years of age	Cohort 3 2 to 5 years of age
Cpre-ss	527.64 pg/mL Geometric Coefficient of Variation 574.47	475.41 pg/mL Geometric Coefficient of Variation 215.66	—

Adverse Events

Topicort® Topical Spray, 0.25%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Director, Clinical Research

Taro Pharmaceuticals

Phone: +1 914-345-9001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place