Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Atopic Dermatitis
- Conditions
- Dermatitis, Atopic
- Interventions
- Drug: DSXS
- Registration Number
- NCT02595008
- Lead Sponsor
- Taro Pharmaceuticals USA
- Brief Summary
this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.
- Detailed Description
The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.
The secondary objectives are to evaluate to evaluate adverse event (AE) profiles of DSXS administered to patients with moderate to severe atopic dermatitis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- Patients with a definite clinical diagnosis of stable atopic dermatitis
- Patient is under the age of 2
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DSXS topical product DSXS treatment with DSXS twice daily for 28 days
- Primary Outcome Measures
Name Time Method Number of Participants With HPA Axis Suppression 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Taro Pharmaceuticals USA Inc.
🇺🇸Hawthorne, New York, United States