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Safety Study in Patients With Scalp Psoriasis Suppression Following Maximal Use Treatment With Topical Product

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: NCT02933502
Recruitment Status : Completed
First Posted : October 14, 2016
Results First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Brief Summary:
An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to SevereScalp Psoriasis

Condition or disease Intervention/treatment Phase
Scalp Psoriasis Drug: DSXS topical product Phase 2

Detailed Description:
  • Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis.
  • Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
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 1538b Topical Product Applied Once-daily in Patients With Moderate to Severe Scalp Psoriasis
Actual Study Start Date : July 11, 2016
Actual Primary Completion Date : September 20, 2017
Actual Study Completion Date : January 2, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: DSXS topical product
treatment with DSXS once daily for 28 days
Drug: DSXS topical product
treatment daily for 28 days
Other Name: Active




Primary Outcome Measures :
  1. Number of Participants With HPA Axis Suppression [ Time Frame: day 28 ]
    Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or non-pregnant, non-lactating females 12-17 years of age.

Exclusion Criteria:

  • Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.

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): NCT02933502


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] July 5, 2016
Statistical Analysis Plan  [PDF] April 24, 2017


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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02933502     History of Changes
Other Study ID Numbers: DSXS 1538b
First Posted: October 14, 2016    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