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| Sponsor: | Stiefel, a GSK Company |
|---|---|
| Information provided by: | Stiefel, a GSK Company |
| ClinicalTrials.gov Identifier: | NCT00703846 |
Purpose
Open-label, multicenter, single-group study to assess the long-term safety of twice daily treatment with Extina (ketoconazole) Foam, 2% in subjects with seborrheic dermatitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Seborrheic Dermatitis |
Drug: Extina (ketoconazole) foam, 2% |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
| Official Title: | A Phase 4, Open-Label Study to Assess the Long-Term Safety of Extina (Ketoconazole) Foam, 2% in the Treatment of Seborrheic Dermatitis. |
| Enrollment: | 501 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Open Label: Experimental
Open Label
|
Drug: Extina (ketoconazole) foam, 2%
All subjects will apply Extina (ketoconazole) Foam, 2% topically twice a day (morning and evening) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest. Study product should be applied at the first sign of a seborrheic dermatitis flare, and twice daily applications should continue until the area(s) has cleared.
|
The study subjects must have seborrheic dermatitis and will apply Extina (ketoconazole) Foam, 2% topically twice a day (morning and evening) to all seborrheic dermatitis lesions on the face, scalp, ears, neck, and chest until resolution throughout the 12 month study period.
Study visits will occur at baseline (day 1) and at weeks 4, 8, 16, 26, 39, and 52 (or early withdrawal). Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, withdrawals from the study, and results of safety laboratory tests.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| United States, Delaware | |
| Guy Webster | |
| Hockessin, Delaware, United States, 19707 | |
| United States, Florida | |
| The Dermatology and Aesthetic Center | |
| Boca Raton, Florida, United States, 33486 | |
| Dermatology Associates & Research | |
| Coral Gables, Florida, United States, 33134 | |
| Spencer Dermatology & Skin Surgery | |
| St. Petersburg, Florida, United States, 33716 | |
| The Weiss Skin Institute | |
| Boca Raton, Florida, United States, 33428 | |
| United States, Louisiana | |
| Tulane University | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Massachusettes General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Henry Ford Medical Center | |
| Detroit, Michigan, United States, 48202 | |
| United States, North Carolina | |
| Dermatology Consulting Services | |
| High Point, North Carolina, United States, 27262 | |
| Wake Forest University Health Sciences | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Oregon | |
| Oregon Dermatology and Research Center | |
| Portland, Oregon, United States, 97210 | |
| United States, Rhode Island | |
| Clinical Partners, LLC | |
| Johnston, Rhode Island, United States, 02919 | |
| United States, Texas | |
| Dermatology Treatment & Research Center | |
| Dallas, Texas, United States, 75230 | |
| Baylor Research Institute | |
| Dallas, Texas, United States, 75246 | |
| Arlington Center for Dermatology | |
| Arlington, Texas, United States, 76011 | |
| University of Texas Southwestern Medical Center | |
| Dallas, Texas, United States, 75930 | |
| DermReserach, Inc. | |
| Austin, Texas, United States, 78759 | |
| United States, Virginia | |
| Virginia Clinical Research, Inc. | |
| Norfolk, Virginia, United States, 23507 | |
| Study Director: | David A Angulo, MD | Stiefel Labortories, Inc., Sr. Director Global Clinical Research |
More Information
| Responsible Party: | Stiefel Laboratories, Inc. ( Jason Mann, Director, Global Clinical Operations ) |
| Study ID Numbers: | U0275-01 |
| Study First Received: | June 20, 2008 |
| Last Updated: | June 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00703846 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Dermatitis Seborrheic Dermatitis |
|
Dermatitis, Seborrheic Anti-Infective Agents Skin Diseases Therapeutic Uses Antifungal Agents Skin Diseases, Eczematous |
Sebaceous Gland Diseases Ketoconazole Skin Diseases, Papulosquamous Pharmacologic Actions Dermatitis |