Last updated: 11/07/2018 07:54:29
STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2%
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: Extina (ketoconazole) Foam, 2% was approved for marketing in theUnited States (US) in June 2007. Extina foam is indicated for topicaltreatment of seborrheic dermatitis in immunocompetent patients 12 yearsof age and older. The approved dosing regimen is twice daily for4 weeks.The treatment of recurrent seborrheic dermatitis demands a topicalpreparation that is safe for both short-term and chronic application. Thisstudy is being conducted in order to obtain long-term safety data on theuse of Extina (ketoconazole) Foam, 2% in the treatment of seborrheicdermatitis.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with any adverse event (AE)
Timeframe: From baseline through 52 weeks
Secondary outcomes:
Mean change from baseline in skin assessments for erythema at Weeks 4, 8, 16, 26, 39, and 52 (or early termination)
Timeframe: Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)
Mean change from baseline in skin assessments for scaling at Weeks 4, 8, 16, 26, 39, and 52 (or early termination)
Timeframe: Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)
Mean change from baseline in skin assessments for pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or early termination)
Timeframe: Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)
Mean change from baseline in Investigator’s Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or early termination)
Timeframe: Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination)
Median number of flares
Timeframe: From baseline through 52 weeks
Median number of flare days
Timeframe: From baseline through 52 weeks
Mean change from baseline for the Global Score of the participant-completed Skindex-29 quality of life questionnaire at Week 52 (or Early Termination)
Timeframe: Baseline and Week 52 (or Early Termination)
Mean change from baseline for the Symptomatic Score of the participant-completed Skindex-29 quality of life questionnaire at Week 52 (or Early Termination)
Timeframe: Baseline and Week 52 (or Early Termination)
Mean change from baseline for the Emotional Score of the participant-completed Skindex-29 quality of life questionnaire at Week 52 (or Early Termination)
Timeframe: Baseline and Week 52 (or Early Termination)
Mean change from baseline for the Functional Score of the participant-completed Skindex-29 quality of life questionnaire at Week 52 (or Early Termination)
Timeframe: Baseline and Week 52 (or Early Termination)
Interventions:
Drug: Ketoconazole
Enrollment:
498
Observational study model:
Not applicable
Primary completion date:
2010-12-04
Time perspective:
Not applicable
Clinical publications:
Zoë D Draelos, MD, Steven R Feldman, MD, PhD, Victoria Butners, BSc, and Alessandra B Alió Saenz, MD . Long-term safety of ketoconazole foam, 2% in the treatment of seborrheic dermatitis: results of a Phase IV, open-label study.. J Drugs Dermatol. 2013;12(1):e1-6.
Medical condition
Dermatitis, Seborrheic
Product
ketoconazole
Collaborators
GSK
Study date(s)
June 2008 to April 2010
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Subjects must fulfill all of the following conditions or characteristics in order to be
- considered for study enrollment:
- Subjects with any of the following conditions or characteristics will be excluded from study
- enrollment:
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects must fulfill all of the following conditions or characteristics in order to be considered for study enrollment: 1. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures are performed. For subjects between the ages of 12 and 17 years, a parent or legal guardian must be capable of understanding and willing to sign informed consent and subject must be capable of understanding and willing to sign an adolescent assent. 2. Male or female subjects 12 years of age or older. 3. Able to complete the study and to comply with study instructions. 4. Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which includes oral contraception, injectable or implantable methods, or intrauterine devices). Barrier methods of contraception are not acceptable. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. Abstinence is considered an appropriate barrier control method. 5. Seborrheic dermatitis on the face, scalp, ears, neck, or chest with an ISGA of 2, 3, or 4 at baseline 6. Subjects must have a discrete, evaluable target area of at least 0.5 cm2, with a score of 2, 3, or 4 for erythema and scaling on the Seborrheic Dermatitis Grading Scale
Exclusion criteria:
- Subjects with any of the following conditions or characteristics will be excluded from study enrollment: 1. Use of systemic antifungal agents, corticosteroids or other immunosuppressive therapies, or systemic retinoids within 4 weeks prior to the baseline visit. 2. Use of topical antifungal therapy, corticosteroid therapy, or calcineurin inhibitors to the face, scalp, ears, neck, or chest within 2 weeks prior to the baseline visit. 3. Use of any investigational drugs within 8 weeks prior to the baseline visit, or subjects who are scheduled to receive an investigative drug other than the study product during the period of the study. 4. History of known or suspected intolerance to any of the ingredients of the study product. 5. Female subjects who are pregnant, trying to become pregnant, or lactating. 6. Any clinically relevant abnormal vital signs or findings on the physical examination. 7. A clinically relevant history of abuse of alcohol or other drugs. 8. Any major illness within 30 days prior to the baseline visit. 9. Subjects with any clinically significant condition which would, in the opinion of the investigator, compromise the subject’s participation in the study. 10. Subjects who are immunocompromised. 11. Considered unable or unlikely to attend the necessary visits. 12. Employees of Stiefel Laboratories or a contract research organization involved in the study, or an immediate family member (partner, offspring, parents, siblings, or sibling’s offspring) of an employee. 13. Currently using any medication, which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk. 14. Only one subject per household may be entered into the study. These inclusion and exclusion criteria will be strictly adhered to throughout the study.
Trial location(s)
No location data available.
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-12-04
Actual study completion date
2010-12-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website