Trial Outcomes & Findings for Effects of Desoximetasone Spray 0.25% on Moderate to Severe Plaque Psoriasis (NCT NCT01206387)

NCT ID: NCT01206387

Last Updated: 2017-06-05

Results Overview

A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

120 participants

Primary outcome timeframe

28 days

Results posted on

2017-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Desoximetasone Spray 0.25% Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days	Placebo placebo comparator: Placebo administered to affected area twice a day for 28 days
Overall Study STARTED	60	60
Overall Study COMPLETED	59	60
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Desoximetasone Spray 0.25% on Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Desoximetasone Spray 0.25% n=60 Participants Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days	Placebo n=60 Participants placebo comparator: Placebo administered to affected area twice a day for 28 days	Total n=120 Participants Total of all reporting groups
Age, Continuous	50.67 years STANDARD_DEVIATION 13.86 • n=5 Participants	52.55 years STANDARD_DEVIATION 15.56 • n=7 Participants	51.61 years STANDARD_DEVIATION 14.71 • n=5 Participants
Age, Categorical <=18 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=5 Participants	29 Participants n=7 Participants	65 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	17 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	43 Participants n=7 Participants	85 Participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	60 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Primary Efficacy Analysis at Day 28 Clinical Success (ITT)

A patient is considered a Clinical Success if the Physician's Global Assessment (PGA) is 0 (clear) or 1 (almost clear).

Outcome measures

Outcome measures
Measure	Desoximetasone Spray 0.25% n=59 Participants Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days	Placebo n=60 Participants placebo comparator: Placebo administered to affected area twice a day for 28 days
Clinical Success	18 participants	3 participants

PRIMARY outcome

Timeframe: 28 days

A patient is considered a Treatment Success for the Target Lesions if the target lesion has a score of 0 or 1 on the Target Lesion Severity Score (TLSS)for each of each of the three signs and symptoms (erythema, scaling and plaque elevation).

Outcome measures

Outcome measures
Measure	Desoximetasone Spray 0.25% n=59 Participants Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days	Placebo n=60 Participants placebo comparator: Placebo administered to affected area twice a day for 28 days
Treatment Success	23 participants	4 participants

SECONDARY outcome

Timeframe: Baseline and day 28

Population: All participants enrolled in this study were included in this intent-to-treat (ITT) analysis. Results are presented as observed

In the Physician Global Assessment of psoriasis is a score based on physician assessment of overall disease severity for all lesions assessed at baseline and at Day 28. The PGA score range: from 0 (Clear=No Psoriatic lesions, i.e. no plaque formation; no erythema, no induration, no scaling) to 5 (Very Severe=Coarse scaling with pronounced cracking and fissures. Erythema is dark red with induration. Plaques are markedly elevated with sharp and hard edges). The first evaluation was for the change from baseline in PGA, using a two-sided, α = 0.05 level of significance. If superiority of the test product over its vehicle was demonstrated (p\<0.05), then PGA change from baseline values was examined.

Outcome measures

Outcome measures
Measure	Desoximetasone Spray 0.25% n=59 Participants Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days	Placebo n=60 Participants placebo comparator: Placebo administered to affected area twice a day for 28 days
Mean Change From Baseline in Physician Global Assessment (PGA) Score at Day 28 Using ITT.	1.14 units on a scale Standard Deviation 0.9	0.50 units on a scale Standard Deviation 0.68

SECONDARY outcome

Timeframe: Baseline and day 28

Population: Base on intention to treat. All participant with mean change from baseline in TLSS at Day 28

Mean Change from Baseline in Lesion Severity Scale-TLSS (ITT) TLSS of psoriasis is a combined score based on physician assessment of disease severity for the Target Lesion assessed at baseline and at Day 28. The TLSS combined score included summary of individually scored induration (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), erythema (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe), and scaling (as 0=Clear or 1=Almost Clear, or 2=Mild, or 3=Moderate, or 4=Severe, or 5=Very Severe). To be eligible for inclusion in the study, the combined score of all three signs for the Target Lesion must total at least 7 and the patient must have at least a score of 3=Moderate for plaque elevation The first evaluation was for the change from baseline in TLSS, using a two-sided, α = 0.05 level of significance.

Outcome measures

Outcome measures
Measure	Desoximetasone Spray 0.25% n=59 Participants Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days	Placebo n=60 Participants placebo comparator: Placebo administered to affected area twice a day for 28 days
Mean Change From Baseline in Total Lesion Severity Scale (TLSS) (ITT)	4.73 units on a scale Standard Deviation 3.08	1.93 units on a scale Standard Deviation 1.96

SECONDARY outcome

Timeframe: Baseline and day 28

Population: Base on intention to treat. All participant with Mean Change from Baseline in %BSA affected at Day 28

Mean Change from Baseline in percent body surface area (%BSA) affected by Psoriasis The 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 For the %Body Surface Area Affected the "Rule of Nine" was be used. Change From Baseline in Percent Body Surface Area i.e., difference of base percent values \[Percent Body Surface Area at 28 days - Percent Body Surface Area at Baseline\].

Outcome measures

Outcome measures
Measure	Desoximetasone Spray 0.25% n=59 Participants Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days	Placebo n=60 Participants placebo comparator: Placebo administered to affected area twice a day for 28 days
Mean Change From Baseline in Percent Body Surface Area (%BSA) Affected at Day 28	2.24 percentage of body surface area affected Standard Deviation 3.79	0.37 percentage of body surface area affected Standard Deviation 2.05

Adverse Events

Desoximetasone Spray 0.25%

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Desoximetasone Spray 0.25% n=60 participants at risk Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days	Placebo n=60 participants at risk placebo comparator: Placebo administered to affected area twice a day for 28 days
Skin and subcutaneous tissue disorders Application Site Dryness	6.7% 4/60 • Number of events 7 • 3 months Daily questionnaire	8.3% 5/60 • Number of events 6 • 3 months Daily questionnaire
Skin and subcutaneous tissue disorders Application Site Erythema	0.00% 0/60 • 3 months Daily questionnaire	3.3% 2/60 • Number of events 2 • 3 months Daily questionnaire
Skin and subcutaneous tissue disorders Application Site Irritation	0.00% 0/60 • 3 months Daily questionnaire	3.3% 2/60 • Number of events 2 • 3 months Daily questionnaire
Skin and subcutaneous tissue disorders Application Site Pruritus	5.0% 3/60 • Number of events 3 • 3 months Daily questionnaire	10.0% 6/60 • Number of events 6 • 3 months Daily questionnaire
Skin and subcutaneous tissue disorders Arthralgia	3.3% 2/60 • Number of events 2 • 3 months Daily questionnaire	1.7% 1/60 • Number of events 1 • 3 months Daily questionnaire
Gastrointestinal disorders Diarrhoea	3.3% 2/60 • Number of events 2 • 3 months Daily questionnaire	1.7% 1/60 • Number of events 1 • 3 months Daily questionnaire
Nervous system disorders Headache	5.0% 3/60 • Number of events 5 • 3 months Daily questionnaire	1.7% 1/60 • Number of events 3 • 3 months Daily questionnaire
Vascular disorders Hypertension	3.3% 2/60 • Number of events 2 • 3 months Daily questionnaire	0.00% 0/60 • 3 months Daily questionnaire
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	3.3% 2/60 • Number of events 2 • 3 months Daily questionnaire	1.7% 1/60 • Number of events 1 • 3 months Daily questionnaire
Musculoskeletal and connective tissue disorders Pain in Extremity	3.3% 2/60 • Number of events 2 • 3 months Daily questionnaire	0.00% 0/60 • 3 months Daily questionnaire
Nervous system disorders Sinus Headache	0.00% 0/60 • 3 months Daily questionnaire	3.3% 2/60 • Number of events 2 • 3 months Daily questionnaire

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