Trial Outcomes & Findings for Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis (NCT NCT02618759)

Last Updated: 2018-12-10

Results Overview

The number of patients in each treatment group that have clinical success. Clinical Success is at least a 2-grade improvement from the baseline IGA score. The minimum IGA value is 0, and maximum value is 5. A higher number represents a more severe case of plaque psoriasis. Patients are required to have an IGA score of 2 or 3 at baseline, so all clinical success IGA scores will be either 0 or 1.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

119 participants

Primary outcome timeframe

28 Days

Results posted on

2018-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	DSXS1505 To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. DSXS: active treatment Placebo: placebo treatment	Placebo Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. DSXS: active treatment Placebo: placebo treatment
Overall Study STARTED	60	59
Overall Study COMPLETED	58	54
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	DSXS1505 To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. DSXS: active treatment Placebo: placebo treatment	Placebo Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. DSXS: active treatment Placebo: placebo treatment
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	1	0
Overall Study Other Reasons	1	4

Baseline Characteristics

Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DSXS1505 n=60 Participants To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. DSXS: active treatment Placebo: placebo treatment	Placebo n=59 Participants Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. DSXS: active treatment Placebo: placebo treatment	Total n=119 Participants Total of all reporting groups
Age, Continuous	53.6 years STANDARD_DEVIATION 15.2 • n=5 Participants	57.3 years STANDARD_DEVIATION 14.3 • n=7 Participants	55.4 years STANDARD_DEVIATION 14.8 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	23 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	36 Participants n=7 Participants	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants	54 Participants n=7 Participants	110 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Baseline Total BSA	2.0 meters squared STANDARD_DEVIATION 0.3 • n=5 Participants	2.0 meters squared STANDARD_DEVIATION 0.3 • n=7 Participants	2.0 meters squared STANDARD_DEVIATION 0.3 • n=5 Participants
%BSA Affected with Psoriasis	7.2 percent of BSA STANDARD_DEVIATION 1.5 • n=5 Participants	7.5 percent of BSA STANDARD_DEVIATION 1.7 • n=7 Participants	7.3 percent of BSA STANDARD_DEVIATION 1.6 • n=5 Participants
Baseline Investigator's Global Assessment (IGA) Score Clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Investigator's Global Assessment (IGA) Score Minimal	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Investigator's Global Assessment (IGA) Score Mild	16 Participants n=5 Participants	10 Participants n=7 Participants	26 Participants n=5 Participants
Baseline Investigator's Global Assessment (IGA) Score Moderate	44 Participants n=5 Participants	49 Participants n=7 Participants	93 Participants n=5 Participants
Baseline Investigator's Global Assessment (IGA) Score Severe	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Total Lesion Severity Score (TLSS)	8.4 units on a scale STANDARD_DEVIATION 1.4 • n=5 Participants	8.4 units on a scale STANDARD_DEVIATION 1.5 • n=7 Participants	8.4 units on a scale STANDARD_DEVIATION 1.5 • n=5 Participants
Baseline Scaling Score Clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Scaling Score Almost Clear	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Baseline Scaling Score Mild	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Baseline Scaling Score Moderate	40 Participants n=5 Participants	35 Participants n=7 Participants	75 Participants n=5 Participants
Baseline Scaling Score Severe	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Baseline Scaling Score Very Severe	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Erythema Score Clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Erythema Score Almost Clear	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Baseline Erythema Score Mild	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Baseline Erythema Score Moderate	40 Participants n=5 Participants	37 Participants n=7 Participants	77 Participants n=5 Participants
Baseline Erythema Score Severe	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Baseline Erythema Score Very Severe	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Plaque Elevation Clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Plaque Elevation Almost Clear	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Plaque Elevation Mild	14 Participants n=5 Participants	11 Participants n=7 Participants	25 Participants n=5 Participants
Baseline Plaque Elevation Moderate	43 Participants n=5 Participants	43 Participants n=7 Participants	86 Participants n=5 Participants
Baseline Plaque Elevation Severe	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Baseline Plaque Elevation Very Severe	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Psoriasis Area Severity Index (PASI) Score	5.8 units on a scale STANDARD_DEVIATION 2.5 • n=5 Participants	6.2 units on a scale STANDARD_DEVIATION 2.4 • n=7 Participants	6.0 units on a scale STANDARD_DEVIATION 2.5 • n=5 Participants
Target Lesion Size (area)	48.7 centimeters squared STANDARD_DEVIATION 55.1 • n=5 Participants	36.7 centimeters squared STANDARD_DEVIATION 26.3 • n=7 Participants	42.7 centimeters squared STANDARD_DEVIATION 43.5 • n=5 Participants

PRIMARY outcome

Timeframe: 28 Days

Outcome measures

Outcome measures
Measure	DSXS1505 n=60 Participants To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. DSXS: active treatment Placebo: placebo treatment	Placebo n=59 Participants Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. DSXS: active treatment Placebo: placebo treatment
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2	10 Participants	3 Participants

PRIMARY outcome

Timeframe: 28 Days

The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2.

Outcome measures

Outcome measures
Measure	DSXS1505 n=60 Participants To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. DSXS: active treatment Placebo: placebo treatment	Placebo n=59 Participants Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. DSXS: active treatment Placebo: placebo treatment
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2	8 Participants	4 Participants

SECONDARY outcome

Timeframe: 28 Days

The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 3, so any IGA score of 0 or 1 at Day 28 ± 2 would be a treatment success.

Outcome measures

Outcome measures
Measure	DSXS1505 n=44 Participants To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. DSXS: active treatment Placebo: placebo treatment	Placebo n=49 Participants Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. DSXS: active treatment Placebo: placebo treatment
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)	8 Participants	3 Participants

SECONDARY outcome

Timeframe: 28 Days

Outcome measures

Outcome measures
Measure	DSXS1505 n=44 Participants To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. DSXS: active treatment Placebo: placebo treatment	Placebo n=49 Participants Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. DSXS: active treatment Placebo: placebo treatment
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 28 Days

The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 2, so only an IGA score of 0 at Day 28 ± 2 would be a treatment success.

Outcome measures

Outcome measures
Measure	DSXS1505 n=16 Participants To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. DSXS: active treatment Placebo: placebo treatment	Placebo n=10 Participants Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. DSXS: active treatment Placebo: placebo treatment
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 Days

Outcome measures

Outcome measures
Measure	DSXS1505 n=16 Participants To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. DSXS: active treatment Placebo: placebo treatment	Placebo n=10 Participants Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. DSXS: active treatment Placebo: placebo treatment
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)	16 Participants	10 Participants

Adverse Events

DSXS1505

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	DSXS1505 n=60 participants at risk To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%. DSXS: active treatment Placebo: placebo treatment	Placebo n=59 participants at risk Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product. DSXS: active treatment Placebo: placebo treatment
Ear and labyrinth disorders Vertigo	1.7% 1/60 • Number of events 1 • 1 year, 7 months	0.00% 0/59 • 1 year, 7 months
General disorders Application site pain	0.00% 0/60 • 1 year, 7 months	1.7% 1/59 • Number of events 1 • 1 year, 7 months
General disorders Application site paraesthesia	0.00% 0/60 • 1 year, 7 months	1.7% 1/59 • Number of events 1 • 1 year, 7 months
Infections and infestations Cellulitis	0.00% 0/60 • 1 year, 7 months	1.7% 1/59 • Number of events 1 • 1 year, 7 months
Nervous system disorders Headache	3.3% 2/60 • Number of events 2 • 1 year, 7 months	0.00% 0/59 • 1 year, 7 months

Additional Information

Natalie Yantovskiy

Taro Pharmaceuticals U.S.A. Inc

Phone: +1 914-345-9001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place