An Open Label, Safety Study to Assess the Potential for Adrenal Suppression
Phase 2
Completed
- Conditions
- Plaque Psoriasis
- Interventions
- Drug: DSXS topical
- Registration Number
- NCT02932878
- Lead Sponsor
- Taro Pharmaceuticals USA
- Brief Summary
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis
- Detailed Description
To evaluate the potential of DSXS to suppress HPA axis function in patients with mild to moderate plaque psoriasis.
To evaluate the efficacy parameters and adverse event (AE) profile of DSXS administered to patients with mild to moderate plaque psoriasis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Male or non pregnant, non lactating females
Exclusion Criteria
- Patients under 2 years of age
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DSXS topical DSXS topical administered twice daily for 28 days
- Primary Outcome Measures
Name Time Method Proportion of Patients in the Study With HPA Axis Suppression 28 Days Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Taro Pharmaceuticals USA Inc.
🇺🇸Hawthorne, New York, United States