Trial Outcomes & Findings for Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study (NCT NCT01018134)

Last Updated: 2014-08-05

Results Overview

The primary endpoint was the proportion of patients in each treatment group who were considered a Clinical Success (PGA score of 0 or 1) at Day 28 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation) The primary measure of efficacy was evaluated using those patients eligible for inclusion in the ITT population. On a seven point grade PGA scale a patient will be considered a Clinical Success if: the patient's PGA score is 0 or 1. A score of 0 = Clear or 1= Almost Clear was considered clinical success. A patient will be considered a Clinical Failure if: the patient's PGA score is \> 1, the patient was considered to have an insufficient therapeutic response

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

151 participants

Primary outcome timeframe

28 days

Results posted on

2014-08-05

Participant Flow

Participant milestones

Participant milestones
Measure	Desoximetasone 0.05% Once Daily Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days	Desoximetasone 0.05% Twice Daily Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days	Desoximetasone 0.25% Once Daily Desoximetasone topical spray 0.25% administered once daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days	Desoximetasone 0.25% Twice Daily Desoximetasone topical spray 0.25% administered twice daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days	Vehicle Once Daily Vehicle administered to affected areas once daily Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days	Vehicle Twice Daily Vehicle administered to affected areas twice daily Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days
Overall Study STARTED	30	31	30	29	15	15
Overall Study COMPLETED	30	30	29	29	15	15
Overall Study NOT COMPLETED	0	1	1	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Desoximetasone 0.05% Once Daily n=30 Participants Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days	Desoximetasone 0.05% Twice Daily n=31 Participants Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days	Desoximetasone 0.25% Once Daily n=30 Participants Desoximetasone topical spray 0.25% administered once daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days	Desoximetasone 0.25% Twice Daily n=29 Participants Desoximetasone topical spray 0.25% administered twice daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days	Vehicle Once Daily n=15 Participants Vehicle administered to affected areas once daily Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days	Vehicle Twice Daily n=15 Participants Vehicle administered to affected areas twice daily Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days	Total n=150 Participants Total of all reporting groups
Age, Continuous	53.60 years STANDARD_DEVIATION 15.21 • n=5 Participants	45.06 years STANDARD_DEVIATION 13.04 • n=7 Participants	51.60 years STANDARD_DEVIATION 12.67 • n=5 Participants	50.62 years STANDARD_DEVIATION 14.54 • n=4 Participants	53.53 years STANDARD_DEVIATION 12.92 • n=21 Participants	49.60 years STANDARD_DEVIATION 13.30 • n=8 Participants	50.66 years STANDARD_DEVIATION 13.61 • n=8 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	13 Participants n=7 Participants	14 Participants n=5 Participants	11 Participants n=4 Participants	1 Participants n=21 Participants	7 Participants n=8 Participants	58 Participants n=8 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	18 Participants n=7 Participants	16 Participants n=5 Participants	18 Participants n=4 Participants	14 Participants n=21 Participants	8 Participants n=8 Participants	92 Participants n=8 Participants
Region of Enrollment United States	30 participants n=5 Participants	31 participants n=7 Participants	30 participants n=5 Participants	29 participants n=4 Participants	15 participants n=21 Participants	15 participants n=8 Participants	150 participants n=8 Participants

PRIMARY outcome

Timeframe: 28 days

Population: The primary measure of efficacy was based on the ITT population. One hundred fifty (150) patients used the study medication and were included in the analysis of safety. Two patients withdrew consent and did not have end of study efficacy procedures performed and were excluded from the efficacy analysis.

Outcome measures

Outcome measures
Measure	Desoximetasone 0.05% Once Daily n=30 Participants Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days	Desoximetasone 0.05% Twice Daily n=30 Participants Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days	Desoximetasone 0.25% Once Daily n=29 Participants Desoximetasone topical spray 0.25% administered once daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days	Desoximetasone 0.25% Twice Daily n=29 Participants Desoximetasone topical spray 0.25% administered twice daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days	Vehicle Once Daily n=15 Participants Vehicle administered to affected areas once daily Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days	Vehicle Twice Daily n=15 Participants Vehicle administered to affected areas twice daily Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days
Number of Participants in Each Treatment Group With Clinical Cure: Physician's Global Assessment (PGA) Score = 0 or 1 at Day 28	13.33 percentage of participants	10.00 percentage of participants	20.69 percentage of participants	37.93 percentage of participants	6.67 percentage of participants	6.67 percentage of participants

PRIMARY outcome

Timeframe: Day 28

The proportion of patients in each treatment group who were considered a Treatment Success for the target lesion (a score of 0 or 1 for each of the three signs/symptoms (i.e., scaling, erythema and plaque elevation)) at Day 28. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components. A TLS score of 0 = Clear or 1= Almost Clear was considered treatment success.

Outcome measures

Outcome measures
Measure	Desoximetasone 0.05% Once Daily n=30 Participants Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days	Desoximetasone 0.05% Twice Daily n=30 Participants Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days	Desoximetasone 0.25% Once Daily n=29 Participants Desoximetasone topical spray 0.25% administered once daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days	Desoximetasone 0.25% Twice Daily n=29 Participants Desoximetasone topical spray 0.25% administered twice daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days	Vehicle Once Daily n=15 Participants Vehicle administered to affected areas once daily Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days	Vehicle Twice Daily n=15 Participants Vehicle administered to affected areas twice daily Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days
Number of Participants in Each Treatment Group With Treatment Success for the Target Lesion (Total Lesion Severity Scale (TLSS) a Score of 0 or 1).	6.67 percentage of Participants	16.67 percentage of Participants	34.48 percentage of Participants	31.03 percentage of Participants	6.67 percentage of Participants	6.67 percentage of Participants

SECONDARY outcome

Timeframe: Day 28

Population: The Intent-to-Treat (ITT) population was used for the secondary endpoint analysis.

Physician Global Assessment (PGA) of Psoriasis is scored based on dermatologist's assessment of disease averaged over all lesions of face, genitals, or intertriginous area (i.e., breast fold, gluteal crease, axilla). Overall lesions were graded for plaque formation, induration, erythema, and scaling; range: 0 (clear) to 5 (very severe). The severity score was summed and averaged after which the total average is rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe; 5=very severe). PGA response was defined as 0 (clear) or 1 (almost clear) Higher scores indicate greater severity of disease.

Outcome measures

Outcome measures
Measure	Desoximetasone 0.05% Once Daily n=30 Participants Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days	Desoximetasone 0.05% Twice Daily n=30 Participants Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days	Desoximetasone 0.25% Once Daily n=29 Participants Desoximetasone topical spray 0.25% administered once daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days	Desoximetasone 0.25% Twice Daily n=29 Participants Desoximetasone topical spray 0.25% administered twice daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days	Vehicle Once Daily n=15 Participants Vehicle administered to affected areas once daily Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days	Vehicle Twice Daily n=15 Participants Vehicle administered to affected areas twice daily Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days
Mean Change From Baseline in PGA Score at Day 28 Using the ITT	0.63 units on a scale Standard Deviation 0.93	0.57 units on a scale Standard Deviation 0.68	0.86 units on a scale Standard Deviation 0.79	1.24 units on a scale Standard Deviation 0.99	0.40 units on a scale Standard Deviation 0.74	0.67 units on a scale Standard Deviation 0.62

SECONDARY outcome

Timeframe: Day 28

Population: The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.

Each lesion was evaluated for 3 components: erythema, plaque elevation, and scaling. Each component was given a score using the following scale: 0=clear, 1=Almost Clear, 2=Mild, 3=Moderate, 4=Severe, 5=Very Severe., with increasing score reflecting increased lesion severity. The TLS score is calculated as the sum of the 3 components.

Outcome measures

Outcome measures
Measure	Desoximetasone 0.05% Once Daily n=30 Participants Desoximetasone topical spray 0.05% administered once daily to affected area Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days	Desoximetasone 0.05% Twice Daily n=30 Participants Desoximetasone topical spray 0.05% administered twice daily to affected area Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days	Desoximetasone 0.25% Once Daily n=29 Participants Desoximetasone topical spray 0.25% administered once daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days	Desoximetasone 0.25% Twice Daily n=29 Participants Desoximetasone topical spray 0.25% administered twice daily to affected area Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days	Vehicle Once Daily n=15 Participants Vehicle administered to affected areas once daily Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days	Vehicle Twice Daily n=15 Participants Vehicle administered to affected areas twice daily Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days
Mean Change From Baseline in Total Lesion Severity Score (TLSS) at Day 28	2.33 units on a scale Standard Deviation 2.51	2.70 units on a scale Standard Deviation 2.05	3.79 units on a scale Standard Deviation 3.20	4.55 units on a scale Standard Deviation 3.03	2.80 units on a scale Standard Deviation 2.21	3.00 units on a scale Standard Deviation 1.81

SECONDARY outcome

Timeframe: Day 28

Population: The Intent-to-Treat (ITT) population was used for the secondary efficacy analysis after 28 days of treatment.

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.