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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: DSXS topical

• Registration Number: NCT02932891
• Lead Sponsor: Taro Pharmaceuticals USA

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 Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-13
• Primary Completion: 2017-04-14
• Study Completion: 2017-12-12
• Results First Submitted: 2018-11-12
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-05
• Last Update Submitted: 2018-12-05
• Results First Posted: 2018-12-07
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DSXS topical	DSXS topical	active treatment

Primary Outcome Measures

Name	Time	Method
The Number of Patients in the Study With HPA Axis Suppression	29 Days	Hypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator

Trial Locations

Locations (1)

Taro Pharmaceuticals USA Inc.; 🇺🇸 Hawthorne, New York, United States