NCT02933866

Brief Summary

A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with Mild to Severe Scalp Psoriasis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
371

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2016

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

March 11, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2016

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2017

Completed
1.2 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

8 months

First QC Date

October 12, 2016

Results QC Date

November 12, 2018

Last Update Submit

November 12, 2018

Conditions

Scalp Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success

    Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2

    Day 29

Study Arms (2)

DSXS topical

EXPERIMENTAL

applied once daily for 28 days

Drug: DSXS topical

Vehicle topical

PLACEBO COMPARATOR

applied once daily for 28 days

Drug: Vehicle topical

Interventions

DSXS topicalDRUG

topical treatment

Also known as: Active
DSXS topical
Vehicle topicalDRUG

topical treatment

Also known as: placebo
Vehicle topical

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or non-pregnant, non-lactating females 18 years of age and older.

You may not qualify if:

  • Females who are pregnant, lactating or likely to become pregnant during the study.

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

October 12, 2016

First Posted

October 14, 2016

Study Start

March 11, 2016

Primary Completion

November 16, 2016

Study Completion

September 29, 2017

Last Updated

December 6, 2018

Results First Posted

December 6, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)