Trial Outcomes & Findings for Effects of Desoximetasone Spray 0.25% in Patients With Moderate to Severe Plaque Psoriasis (NCT NCT01206660)

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

2014-07-03

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Desoximetasone Spray 0.25% in Patients With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Desoximetasone Spray 0.25% n=60 Participants Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days	Placebo n=60 Participants Placebo administered to affected area twice a day for 28 days placebo: Placebo administered to affected area twice a day for 28 days	Total n=120 Participants Total of all reporting groups
Age, Continuous	48.03 years STANDARD_DEVIATION 14.29 • n=99 Participants	53.55 years STANDARD_DEVIATION 14.82 • n=107 Participants	50.79 years STANDARD_DEVIATION 14.56 • n=206 Participants
Age, Categorical <=18 years	17 Participants n=99 Participants	13 Participants n=107 Participants	30 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=99 Participants	31 Participants n=107 Participants	65 Participants n=206 Participants
Age, Categorical >=65 years	9 Participants n=99 Participants	16 Participants n=107 Participants	25 Participants n=206 Participants
Sex: Female, Male Female	23 Participants n=99 Participants	25 Participants n=107 Participants	48 Participants n=206 Participants
Sex: Female, Male Male	37 Participants n=99 Participants	35 Participants n=107 Participants	72 Participants n=206 Participants
Region of Enrollment United States	60 participants n=99 Participants	60 participants n=107 Participants	120 participants n=206 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Analysis was conducted using Intent-to-Treat (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=60 Participants Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days	Placebo n=60 Participants Placebo administered to affected area twice a day for 28 days placebo: Placebo administered to affected area twice a day for 28 days
Clinical Success ITT	32 participants	11 participants

PRIMARY outcome

Timeframe: Day 28

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 the three signs and symptoms (erythema, scaling and plaque elevation).

Outcome measures

Outcome measures
Measure	Desoximetasone Spray 0.25% n=60 Participants Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days	Placebo n=60 Participants Placebo administered to affected area twice a day for 28 days placebo: Placebo administered to affected area twice a day for 28 days
Treatment Success	32 participants	10 participants

SECONDARY outcome

Timeframe: Day 28

Population: ITT Population. Participants who returned for at least one post baseline visit and/or provided an assessment for pruritus were evaluated; not all participants returned for every study visit.

Physician Global Assessment (PGA) of Psoriasis: score 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 induration, erythema, and scaling; range: 0 (no evidence) to 5 (severe). The sum of the 3 scores was divided by 3 to obtain a final PGA score. Higher scores indicate greater severity of disease.

Outcome measures

Outcome measures
Measure	Desoximetasone Spray 0.25% n=60 Participants Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days	Placebo n=60 Participants Placebo administered to affected area twice a day for 28 days placebo: Placebo administered to affected area twice a day for 28 days
Physician's Global Assessment (PGA) of Psoriasis Score at Day 28.	1.73 units on a scale Standard Deviation 1.06	0.85 units on a scale Standard Deviation 0.94

Adverse Events

Desoximetasone Spray 0.25%

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 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 topical spray 0.25% administered to affected area twice a day for 28 days 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 administered to affected area twice a day for 28 days placebo: Placebo administered to affected area twice a day for 28 days
Skin and subcutaneous tissue disorders Application Site Irritation	6.7% 4/60 • Number of events 5 • 3 months	5.0% 3/60 • Number of events 3 • 3 months
Skin and subcutaneous tissue disorders Application Site Pain	0.00% 0/60 • 3 months	3.3% 2/60 • Number of events 3 • 3 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