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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.

Current Primary Outcome: Number of Participants With Any Adverse Event (AE) [ Time Frame: From baseline through 52 weeks ]

Original Primary Outcome: To assess the long-term safety of Extina (ketoconazole) Foam, 2% in the treatment of seborrheic dermatitis. [ Time Frame: 1 year ]

Current Secondary Outcome:

• Mean Change From Baseline in Skin Assessments for Erythema at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) [ Time Frame: Baseline and 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.
• Mean Change From Baseline in Skin Assessments for Scaling at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) [ Time Frame: Baseline and 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.
• Mean Change From Baseline in Skin Assessments for Pruritus at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) [ Time Frame: Baseline and 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 pruritis ranges from 0 to 4; 0=No itching; 1=Minimal: rarely aware of itching; 2=Mild: only aware of itching at times; only present when relaxing; not present when focused on other activities; 3=Moderate: often aware of itching; annoying; sometimes disturbs sleep and daytime activities; 4=Severe: constant itching; distressing; frequent sleep disturbance; interferes with activities. Pruritus is defined as an itching/scratching sensation.
• Mean Change From Baseline in Investigator's Static Global Assessment (ISGA) at Weeks 4, 8, 16, 26, 39, and 52 (or Early Termination) [ Time Frame: Baseline and Weeks 4, 8, 16, 26, 39, and 52 (or early termination) ]
  This seborrhoeic dermatitis-specific ISGA scale (range=0-4) is used to assess skin condition severity without considering changes over time ("static"). 0=clear, except for minor residual discoloration; 1-4=majority of lesions have average scaling/erythema scores of 1-4, respectively. 1=almost clear, occasional fine scale, faint erythema/barely perceptible plaque thickness; 2= mild, fine scale with light coloration/mild plaque elevation; 3=moderate, coarse scale with moderate red coloration/moderate plaque thickness; 4=severe, thick tenacious scale with deep coloration/severe plaque thickness.
• Median Number of Flares [ Time Frame: From baseline through 52 weeks ]
  The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare is defined as a clinical diagnosis and presentation of seborrheic dermatitis that shows as an erythematous, thin, scaly patch with a greasy sandpaper texture that varies depending on disease severity. Flares are commonly seen on the scalp, nasal folds, eyebrows, glabella, upper eyelids, retroauricular/external ear canal, and midchest areas.
• Median Number of Flare Days [ Time Frame: From baseline through 52 weeks ]
  The median number of flare days for all participants was calculated based on data self-reported in diaries that participants kept during the study. The median number of flares for all participants was calculated based on data self-reported in diaries that participants kept during the study. A flare day is defined as a day on which flare signs and symptoms for seborrheic dermatitis (erythema, scaling, and pruritus of the target area) occurred.
• Mean Change From Baseline for the Global Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination) [ Time Frame: Baseline and Week 52 (or Early Termination) ]
  Skindex-29 is a 3-component (symptomatic, emotional, and functional) self-administered questionnaire (comprised of 30 questions) used to comprehensively measure the complex effects of skin diseases on a participant's quality of life. Participants were asked to answer questions based on a 5-point scale concerning their feelings over the past 4 weeks about the skin condition that has bothered them the most: 1, never; 2, rarely; 3, sometimes; 4, often; 5, all the time. The Global Score is the sum of the 30 question scores; total score ranges from 30 to 150.
• Mean Change From Baseline for the Symptomatic Score of the Participant-completed Skindex-29 Quality of Life Questionnaire at Week 52 (or Early Termination) [ Time Frame: Baseline and
  
  

  Original Secondary Outcome:
  
  Information By: GlaxoSmithKline
  

  Dates:
  Date Received: June 20, 2008
  Date Started: June 2008
  Date Completion:
  Last Updated: December 1, 2016
  Last Verified: December 2016