Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS
Phase 2
Completed
- Conditions
- Psoriasis
- Interventions
- Drug: DSXS Topical product
- Registration Number
- NCT02933528
- Lead Sponsor
- Taro Pharmaceuticals USA
- Brief Summary
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment with DSXS .
- Detailed Description
Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis. Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Male or non-pregnant, non-lactating females 18 years of age or older.
- IRE-approved, signed informed consent form that 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 product DSXS Topical product treatment with DSXS once 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 stimulation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Taro Pharmaceuticals USA, Inc.
🇺🇸Hawthorne, New York, United States