NCT02413229

Brief Summary

The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_2

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

April 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

December 6, 2018

Completed
Last Updated

December 6, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

April 6, 2015

Results QC Date

November 12, 2018

Last Update Submit

November 12, 2018

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Clinical Response of Success

    The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1.

    28 Days

Study Arms (2)

DSXS1411

EXPERIMENTAL

DSXS applied once a day for a total of 28 days.

Drug: DSXS1411

Placebo

PLACEBO COMPARATOR

Placebo (vehicle) applied once a day for a total of 28 days.

Drug: Placebo

Interventions

DSXS1411DRUG

DSXS (Taro Pharmaceuticals Inc.)

Also known as: Active
DSXS1411
PlaceboDRUG

Placebo (vehicle) (Taro Pharmaceuticals Inc.)

Also known as: vehicle
Placebo

Eligibility Criteria

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

You may qualify if:

  • Male or non-pregnant, non-lactating females age 12 and older.
  • Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's Global Assessment score of at least 3 at screening.

You may not qualify if:

  • Under 12 years of age.
  • Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other concomitant topical therapies during the study.
  • Has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2015

First Posted

April 9, 2015

Study Start

April 1, 2015

Primary Completion

September 14, 2015

Study Completion

January 29, 2016

Last Updated

December 6, 2018

Results First Posted

December 6, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share