Phase 2
N=24
Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS
Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02933528 ↗Enrolled (actual)
24
Serious AEs
4.4%
Results posted
Dec 2018
Primary outcome: Primary: Proportion of Patients in the Study With HPA Axis Suppression — 1; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DSXS Topical product (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries, Inc.
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients in the Study With HPA Axis Suppression |
1; 13 | — |
Summary
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment with DSXS .
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02933528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.