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An Open Label, Safety Study to Assess the Potential for Adrenal Suppression.

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: NCT02932891
Recruitment Status : Completed
First Posted : October 13, 2016
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Tracking Information
First Submitted Date  ICMJE October 12, 2016
First Posted Date  ICMJE October 13, 2016
Results First Submitted Date  ICMJE November 12, 2018
Results First Posted Date  ICMJE December 7, 2018
Last Update Posted Date December 7, 2018
Actual Study Start Date  ICMJE August 2016
Actual Primary Completion Date April 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
The Number of Patients in the Study With HPA Axis Suppression [ Time Frame: 29 Days ]
Hypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2016)
Proportion of patients in the study with HPA axis suppression [ Time Frame: 29 Days ]
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin
Change History Complete list of historical versions of study NCT02932891 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open Label, Safety Study to Assess the Potential for Adrenal Suppression.
Official Title  ICMJE An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS Topical Product in Patients With Atopic Dermatitis
Brief Summary An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS in Patients with Atopic Dermatitis
Detailed Description To evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe atopic dermatitis.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE Drug: DSXS topical
topical treatment
Other Name: active
Study Arms  ICMJE Experimental: DSXS topical
active treatment
Intervention: Drug: DSXS topical
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 5, 2018)
28
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2016)
50
Actual Study Completion Date  ICMJE December 12, 2017
Actual Primary Completion Date April 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Parent/legal guardian has signed informed consent form, which meets all criteria of current FDA regulations.

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02932891
Other Study ID Numbers  ICMJE DSXS 1502a
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Taro Pharmaceuticals USA
Study Sponsor  ICMJE Taro Pharmaceuticals USA
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novum Pharmaceutical Research Services http://www.novumprs.com/contact
PRS Account Taro Pharmaceuticals USA
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP