Back to resultsAn Open Label, Safety Study to Assess the Potential for Adrenal Suppression.
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DSXS topical
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
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
Sites / Locations
- Taro Pharmaceuticals USA Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DSXS topical
Arm Description
active treatment
Outcomes
Primary Outcome Measures
The Number of Patients in the Study With HPA Axis Suppression
Hypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator
Secondary Outcome Measures
Full Information
NCT ID
NCT02932891
First Posted
October 12, 2016
Last Updated
December 5, 2018
Sponsor
Taro Pharmaceuticals USA
1. Study Identification
Unique Protocol Identification Number
NCT02932891
Brief Title
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression.
Official Title
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS Topical Product in Patients With Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
April 14, 2017 (Actual)
Study Completion Date
December 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DSXS topical
Arm Type
Experimental
Arm Description
active treatment
Intervention Type
Drug
Intervention Name(s)
DSXS topical
Other Intervention Name(s)
active
Intervention Description
topical treatment
Primary Outcome Measure Information:
Title
The Number of Patients in the Study With HPA Axis Suppression
Description
Hypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator
Time Frame
29 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novum Pharmaceutical Research Services
Organizational Affiliation
http://www.novumprs.com/contact
Official's Role
Study Chair
Facility Information:
Facility Name
Taro Pharmaceuticals USA Inc.
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression.
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