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

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ClinicalTrials.gov Identifier: NCT02413229
Recruitment Status : Completed
First Posted : April 9, 2015
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: DSXS1411 Drug: Placebo Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double Blind Vehicle Controlled Dose Ranging Multiple Site Phase 2 Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Moderate to Severe Scalp Psoriasis
Actual Study Start Date : April 2015
Actual Primary Completion Date : September 14, 2015
Actual Study Completion Date : January 29, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: DSXS1411
DSXS applied once a day for a total of 28 days.
Drug: DSXS1411
DSXS (Taro Pharmaceuticals Inc.)
Other Name: Active

Placebo Comparator: Placebo
Placebo (vehicle) applied once a day for a total of 28 days.
Drug: Placebo
Placebo (vehicle) (Taro Pharmaceuticals Inc.)
Other Name: vehicle




Primary Outcome Measures :
  1. Clinical Response of Success [ Time Frame: 28 Days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413229


Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Novum Pharmaceutical Research Services http://www.novumprs.com/contact
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02413229    
Other Study ID Numbers: DSXS 1411
First Posted: April 9, 2015    Key Record Dates
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases