| October 16, 2007 |
| December 8, 2008 |
| July 2007 |
| December 2008 (final data collection date for primary outcome measure) |
| Prior and post treatment serum cortisol values will be compared. [ Time Frame: Up to 29 days of treatment ] [ Designated as safety issue: Yes ] |
| Prior and post treatment serum cortisol values will be compared. [ Time Frame: Up to 29 days of treatment ] |
| Complete list of historical versions of study NCT00546000 on ClinicalTrials.gov Archive Site |
| Record adverse events, skin atrophy, pigmentation change, hematological and chemistry assessments, and changes in atopic dermatitis severity [ Time Frame: Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29 ] [ Designated as safety issue: Yes ] |
| Record adverse events, skin atrophy, pigmentation change, hematological and chemistry assessments, and changes in atopic dermatitis severity [ Time Frame: Over 5-6 visits following the baseline visit through the end of treatment between Day 22-29 ] |
| |
| Cutivate Lotion HPA Axis Pediatric Study |
| A Multi-Center, Open-Label Study to Evaluate the Effect of ALTANA Inc's Cutivate (Fluticasone Propionate) Lotion 0.05% on the Hypothalmic Pituitary Adrenal (HPA) Axis in the Treatment of Atopic Dermatitis in a Pediatric Population |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Open Label, Single Group Assignment |
| Atopic Dermatitis |
| Drug: Fluticasone propionate 0.05% lotion |
| Experimental: Receive between 22 and 29 days of Cutivate lotion treatment |
| |
| |
| Completed |
| 56 |
| December 2008 |
| December 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 3 Months to 12 Months |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00546000 |
| Kathleen Ocasio, Manager, Clinical Research Operations |
| ALT 0434-01-01 |
| Therapeutics, Inc. |
| Nycomed US Inc. |
| Principal Investigator: |
Alan Fleischer Jr., M.D. |
Wake Forest University |
|
| Principal Investigator: |
Lawrence F. Eichenfield, MD |
Rady Children's Hospital, San Diego |
|
| Principal Investigator: |
Elizabeth Connelly, MD |
University of Miami |
|
| Principal Investigator: |
Craig L. Leonardi, MD |
Central Dermatology |
|
| Principal Investigator: |
Lawrence Parish, MD |
Paddington Testing Company, Inc |
|
| Principal Investigator: |
Adelaide A Hebert, MD |
The University of Texas Health Science Center, Houston |
|
| Principal Investigator: |
Sharon Raimer, MD |
University of Texas Medical Branch, Galveston |
|
| Principal Investigator: |
Kenneth E. Bloom, MD |
Dermatology Center for Children and Young Adults |
|
| Principal Investigator: |
David L Kaplan, MD |
Adult & Pediatric Dermatology |
|
| Principal Investigator: |
Stephen W. Shewmake, M.D. |
Centre for Health Care Medical Associates |
|
|
| Therapeutics, Inc. |
| December 2008 |
