A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study

NCT ID: NCT02413229

Last Updated: 2018-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-01-29

Brief Summary

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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.

Detailed Description

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This randomized, double-blind, vehicle-controlled, dose-ranging, parallel-group multi-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS, for the treatment of moderate to severe scalp psoriasis at different application times up to 30 minutes.

Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DSXS1411

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

Group Type EXPERIMENTAL

DSXS1411

Intervention Type DRUG

DSXS (Taro Pharmaceuticals Inc.)

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (vehicle) (Taro Pharmaceuticals Inc.)

Interventions

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DSXS1411

DSXS (Taro Pharmaceuticals Inc.)

Intervention Type DRUG

Placebo

Placebo (vehicle) (Taro Pharmaceuticals Inc.)

Intervention Type DRUG

Other Intervention Names

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Active vehicle

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novum Pharmaceutical Research Services

Role: STUDY_CHAIR

http://www.novumprs.com/contact

Other Identifiers

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DSXS 1411

Identifier Type: -

Identifier Source: org_study_id

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