Trial Outcomes & Findings for Desoximetasone Spray 0.25%, Hypothalamic Pituitary Adrenal (HPA) Axis Study (NCT NCT01043393)

Results Overview

Each patient is assessed at Day 28. A cortisol response test performed at baseline are reevaluated at the conclusion of the study. If the normal cortisol response test measured at baseline is no long present the patient is considered to have demonstrated possible HPA axis suppression.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

28 days

Results posted on

2014-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Psoriasis Involving 10-15% BSA Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days	Psoriasis Involving >15% of BSA Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of \>15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Desoximetasone Spray 0.25%, Hypothalamic Pituitary Adrenal (HPA) Axis Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Psoriasis Involving 10-15% BSA n=12 Participants Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area. Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days	Psoriasis Involving >15% of BSA n=12 Participants Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of \>15% of their body surface area. Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days	Total n=24 Participants Total of all reporting groups
Age, Continuous	52.08 years FULL_RANGE 3.55 • n=5 Participants	46.75 years FULL_RANGE 5.99 • n=7 Participants	49.42 years FULL_RANGE 4.77 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Each patient is assessed at Day 28. A cortisol response test performed at baseline are reevaluated at the conclusion of the study. If the normal cortisol response test measured at baseline is no long present the patient is considered to have demonstrated possible HPA axis suppression.

Outcome measures

Outcome measures
Measure	Psoriasis Involving 10-15% BSA n=12 Participants Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days	Psoriasis Involving >15% of BSA n=12 Participants Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of \>15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days
Proportion of Patients in the Study With Hypothalamic Pituitary Adrenal (HPA) Axis Suppression	2 participants 3.55	3 participants 5.99

SECONDARY outcome

Timeframe: 28 days

Population: No statistical analysis provided for Percentage of Body Surface Area Affected by Psoriasis. As the study is not powered sufficiently to perform efficacy statistical analysis, descriptive statistical analysis are presented on the mean change from baseline in % BSA affected

Body Surface Area (BSA) is a numerical score used to measure the physician's assessment of the percentage of the participant's total BSA involved with psoriasis. BSA = SQRT ((height (cm) X weight (kg))/3600) BSA is in m2, W is weight in kg, and H is height in cm. Total body Surface Area (BSA) in meters squared %Body Surface Area Affected the "Rule of Nine" was be used

Outcome measures

Outcome measures
Measure	Psoriasis Involving 10-15% BSA n=12 Participants Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days	Psoriasis Involving >15% of BSA n=12 Participants Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of \>15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days
Change From Baseline in Percent Body Surface Area (%BSA) Affected by Psoriasis	5.50 percentage of Body Surface Area Affected Standard Deviation 3.55 • Interval 0.0338 to 11.126	3.50 percentage of Body Surface Area Affected Standard Deviation 5.99 • Interval 0.0921 to 1.168

SECONDARY outcome

Timeframe: 28 days

Population: No statistical analysis provided for Percentage of Participants With a Physician's Global Assessment (PGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)

The PGA scale is designed to evaluate the physician's global assessment of the participant's psoriasis based on severity of induration,erythema and scaling. The PGA is assessed on a scale of 0 to 5 (0 = clear, 5 = severe).

Outcome measures

Outcome measures
Measure	Psoriasis Involving 10-15% BSA n=12 Participants Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days	Psoriasis Involving >15% of BSA n=12 Participants Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of \>15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days
Change From Baseline in Physician's Global Assessment (PGA) Score for Psoriasis	1.83 percentage of physician's global assessm Standard Deviation 0.94	1.33 percentage of physician's global assessm Standard Deviation 1.15

Adverse Events

Psoriasis Involving 10-15% BSA

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Psoriasis Involving >15% of BSA

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Psoriasis Involving 10-15% BSA n=12 participants at risk Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days	Psoriasis Involving >15% of BSA n=12 participants at risk Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of \>15% of their body surface area (BSA). Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days
Endocrine disorders Adrenal Suppression	16.7% 2/12 • Number of events 2 • 4 months	25.0% 3/12 • Number of events 3 • 4 months
Skin and subcutaneous tissue disorders Application Site Pruritus	0.00% 0/12 • 4 months	8.3% 1/12 • Number of events 1 • 4 months
Nervous system disorders Headache	8.3% 1/12 • Number of events 2 • 4 months	0.00% 0/12 • 4 months
Skin and subcutaneous tissue disorders Cyst	0.00% 0/12 • 4 months	8.3% 1/12 • Number of events 1 • 4 months
Musculoskeletal and connective tissue disorders Sciatica	0.00% 0/12 • 4 months	8.3% 1/12 • Number of events 1 • 4 months

Additional Information

Director, Clinical Research

Taro Pharmaceuticals U.S.A., Inc.

Phone: 914-345-9001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place