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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which DSXS topical product interacts with the HPA axis in psoriasis patients?
How does DSXS compare to standard-of-care treatments like corticosteroids in managing scalp psoriasis severity?
Are there specific biomarkers that correlate with HPA axis suppression risk in patients using DSXS?
What are the long-term management strategies for adrenal suppression caused by DSXS topical treatment?
What other compounds or combination therapies are being explored by Taro Pharmaceuticals for moderate to severe scalp psoriasis?
Trial Locations
- Locations (1)
Taro Pharmaceuticals USA, Inc.
🇺🇸Hawthorne, New York, United States
Taro Pharmaceuticals USA, Inc.🇺🇸Hawthorne, New York, United States