Phase 4
Completed N=56
Cutivate Lotion HPA Axis Pediatric Study
Source: ClinicalTrials.gov NCT00546000 ↗Enrolled (actual)
56
Serious AEs
1.8%
Results posted
Jul 2014
Primary outcomePrimary: Post Treatment Serum Cortisol Values Will be Compared. — 1 participants
Summary
A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Treatment Serum Cortisol Values Will be Compared. |
1 | — |
| SECONDARY Record Skin Atrophy, Pigmentation Change, Hematological and Chemistry Assessments, and Changes in Atopic Dermatitis Severity |
1; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects are 3-12 months of age
- Subjects diagnosed with Atopic Dermatitis (AD) and have ≥35% of Body Surface Area
- Subjects meet protocol specific AD signs and symptom severity score
Exclusion Criteria
- Subjects with conditions effecting the HPA Axis
- Subjects with clinically significant systemic disease
- Subjects who require treatment with systemic or topical retinoids during the study
- Subjects who have been treated with various chronic therapies identified in the protocol
- Subjects who have received other investigational drug treatment within 30 days prior to study entry
Data sourced from ClinicalTrials.gov (NCT00546000). 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. Informational only — not medical advice.