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Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT02601469
Recruitment Status : Completed
First Posted : November 10, 2015
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Study Description
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Brief Summary:
An open label, safety study to assess the potential for adrenal suppression following maximal use treatment with DSXS administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.

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

Detailed Description:
  1. The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe plaque psoriasis
  2. To evaluate the efficacy parameters, pharmacokinetics and adverse event (AE) profile of DSXS
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients With Plaque Psoriasis.
Actual Study Start Date : September 4, 2015
Actual Primary Completion Date : December 29, 2016
Actual Study Completion Date : August 25, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: DSXS1503
administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.
 Drug: DSXS
twice daily for 28 days
Other Name: Active


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With HPA Axis Suppression [ Time Frame: 28 days ]
    Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a confirmed diagnosis of plaque psoriasis, patients 2-17 years of age with ≥ 10% BSA affected and patients age 18 years of age or older with ≥ 20% BSA affected
  2. Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
  3. Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response

Exclusion Criteria:

  1. Patients under 2 years of age.
  2. Investigator Global Assessment (IGA) of less than 3 (moderate) or greater than 4 (severe) at baseline.
  3. Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e., erythrodermic, exfoliative or pustular psoriasis).
  4. Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response
Contacts and Locations
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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): NCT02601469


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
More Information
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02601469    
Other Study ID Numbers: DSXS 1503
First Posted: November 10, 2015    Key Record Dates
Results First Posted: December 7, 2018
Last Update Posted: December 7, 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