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

Stiefel, a GSK Company498 enrolled

Overview

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.

This is an 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. The study subjects must have seborrheic dermatitis with an Investigator's Static Global Assessment (ISGA) of 2, 3, or 4 at baseline. In addition, 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. 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. All symptom flares should be treated 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). See the study flowchart (section 3) for the assessments to be performed at each visit. Primary Objective: To assess the long-term safety of Extina (ketoconazole) Foam, 2% in the treatment of seborrheic dermatitis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

498

Conditions

Dermatitis, Seborrheic

Interventions

KetoconazoleDRUG

Foam, 2%, Extina will be applied twice daily (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. All symptom flares should be treated throughout the 12-month study period.

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Participants With Any Adverse Event (AE)

An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, which does not necessarily have a causal relationship with the treatment. For a list of all adverse events occurring at or above a frequency threshold of 5% during the course of the study, see the table entitled "Other (Non-Serious) Adverse Events."

Time frame: 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)

Mean change from baseline was calculated as the Week 4, 8, 16, 26, 39, and 52 (or early termination) value minus the baseline value. The grading scale for erythema ranges from 0 to 4; 0=Normal skin without erythema; may have residual hyper/hypopigmentation; 1=Faint erythema; may have residual hyper/hypopigmentation; 2=Light red erythema; may have residual hyper/hypopigmentation; 3=Moderate red coloration; 4=Dusky to deep red coloration. Erythema was defined as redness of the skin caused by increased blood circulation in the capillaries found in the deeper layers of the skin.

Time frame: 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)

Mean change from baseline in skin assessments for scaling was calculated as the Week 4, 8, 16, 26, 39, and 52 (or Early Termination) value minus the baseline value. The grading scale for scaling ranges from 0 to 4; 0=Normal skin with rare fine scale; 1=Minimal: occasional fine scales over less than 10% of the lesions; 2=Mild: fine scales predominate; 3=Moderate: coarse scales predominate; 4=Severe: thick tenacious scales predominate. Scaling of skin is the loss of the outer layer of the epidermis in large, scale-like flakes.

Time frame: 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)

Data from ClinicalTrials.gov

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