Phase 2
N=28
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression.
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT02932891 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: The Number of Patients in the Study With HPA Axis Suppression — 8; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- DSXS topical (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries, Inc.
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients in the Study With HPA Axis Suppression |
8; 9 | — |
Summary
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS in Patients with Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria
- Parent/legal guardian has signed informed consent form, which 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 (NCT02932891). 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.