NCT02618759

Brief Summary

The purpose of this study is to evaluate the therapeutic efficacy and safety of DSXS compared to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 10, 2018

Completed
Last Updated

December 10, 2018

Status Verified

December 1, 2018

Enrollment Period

1.6 years

First QC Date

November 1, 2015

Results QC Date

November 12, 2018

Last Update Submit

December 5, 2018

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

  • Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2

    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.

    28 Days

  • Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2

    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.

    28 Days

Secondary Outcomes (4)

  • 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)

    28 Days

  • 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)

    28 Days

  • 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)

    28 Days

  • 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)

    28 Days

Study Arms (2)

DSXS1505

EXPERIMENTAL

To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%.

Drug: DSXSDrug: Placebo

Placebo

PLACEBO COMPARATOR

Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product.

Drug: DSXSDrug: Placebo

Interventions

DSXSDRUG

active treatment

Also known as: Active
DSXS1505Placebo
PlaceboDRUG

placebo treatment

Also known as: vehicle
DSXS1505Placebo

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • male and non-pregnant females, 12 years of age or older, with a confirmed diagnosis of mild to moderate plaque psoriasis

You may not qualify if:

  • patient is\< 12 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, 10532, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Natalie Yantovskiy
Organization
Taro Pharmaceuticals U.S.A. Inc
Natalie.Yantovskiy@Taro.com
+1 914-345-9001

Study Officials

  • Novum Pharmaceutical Research Services

    http://www.novumprs.com/contact

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2015

First Posted

December 1, 2015

Study Start

August 28, 2015

Primary Completion

March 16, 2017

Study Completion

August 25, 2017

Last Updated

December 10, 2018

Results First Posted

December 10, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)