Safety Study in Patients With Scalp Psoriasis Suppression Following Maximal Use Treatment With Topical Product
Phase 2
Completed
- Conditions
- Scalp Psoriasis
- Interventions
- Drug: DSXS topical product
- Registration Number
- NCT02933502
- Lead Sponsor
- Taro Pharmaceuticals USA
- Brief Summary
An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to SevereScalp Psoriasis
- 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
- 3
Inclusion Criteria
- Male or non-pregnant, non-lactating females 12-17 years of age.
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 Number of Participants With HPA Axis Suppression day 28 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