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Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02618759
Recruitment Status : Completed
First Posted : December 1, 2015
Results First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: DSXS Drug: Placebo Phase 3

Detailed Description:
To evaluate the therapeutic efficacy and safety of dsxs topical spray, 0.15% (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Placebo (vehicle) spray (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to moderate plaque psoriasis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis
Actual Study Start Date : August 28, 2015
Actual Primary Completion Date : March 16, 2017
Actual Study Completion Date : August 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: DSXS1505
To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%.
Drug: DSXS
active treatment
Other Name: Active

Drug: Placebo
placebo treatment
Other Name: vehicle

Placebo Comparator: Placebo
Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product.
Drug: DSXS
active treatment
Other Name: Active

Drug: Placebo
placebo treatment
Other Name: vehicle




Primary Outcome Measures :
  1. Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 [ Time Frame: 28 Days ]
    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.

  2. Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 [ Time Frame: 28 Days ]
    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.


Secondary Outcome Measures :
  1. 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) [ Time Frame: 28 Days ]
    The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 3, so any IGA score of 0 or 1 at Day 28 ± 2 would be a treatment success.

  2. 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) [ Time Frame: 28 Days ]
    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. This measure is limited to patients with a baseline IGA score of 3.

  3. 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) [ Time Frame: 28 Days ]
    The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 2, so only an IGA score of 0 at Day 28 ± 2 would be a treatment success.

  4. 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) [ Time Frame: 28 Days ]
    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. This measure is limited to patients with a baseline IGA score of 2.



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

Exclusion Criteria:

  • patient is< 12 years old.

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): NCT02618759


Locations
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United States, New York
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, United States, 10532
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Novum Pharmaceutical Research Services http://www.novumprs.com/contact
  Study Documents (Full-Text)

Documents provided by Taro Pharmaceuticals USA:
Study Protocol  [PDF] February 21, 2017
Statistical Analysis Plan  [PDF] March 4, 2016

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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02618759    
Other Study ID Numbers: DSXS 1505
First Posted: December 1, 2015    Key Record Dates
Results First Posted: December 10, 2018
Last Update Posted: December 10, 2018
Last Verified: December 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