Last updated: 11/07/2018 07:54:29

STUDY TO ASSESS THE LONG-TERM SAFETY OF EXTINA (KETOCONAZOLE) FOAM, 2%

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GSK study ID
114568
See study documents
Clinicaltrials.gov ID
NCT00703846
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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 the
United States (US) in June 2007. Extina foam is indicated for topical
treatment of seborrheic dermatitis in immunocompetent patients 12 years
of age and older. The approved dosing regimen is twice daily for
4 weeks.
The treatment of recurrent seborrheic dermatitis demands a topical
preparation that is safe for both short-term and chronic application. This
study is being conducted in order to obtain long-term safety data on the
use of Extina (ketoconazole) Foam, 2% in the treatment of seborrheic
dermatitis.
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
    Primary completion date:
    2010-12-04
    Observational study model:
    Not applicable
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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

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