EXTINA SUMMARY
Extina Foam contains 2% ketoconazole USP, an antifungal agent, in a thermolabile hydroethanolic foam for topical application.
Extina® (ketoconazole) Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Safety and efficacy of Extina Foam for treatment of fungal infections have not been established.
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NEWS HIGHLIGHTSMedia Articles Related to Extina (Ketoconazole Topical)
ketoconazole, Nizoral, Extina, Xolegel, Kuric
Source: MedicineNet Ringworm Specialty [2008.12.15]
Title: ketoconazole, Nizoral, Extina, Xolegel, Kuric
Category: Medications
Created: 12/31/1997
Last Editorial Review: 12/15/2008
Published Studies Related to Extina (Ketoconazole Topical)
An open, randomized, prospective, comparative study of topical pimecrolimus 1% cream and topical ketoconazole 2% cream in the treatment of seborrheic dermatitis. [2009]
BACKGROUND: Seborrheic dermatitis (SD) is a chronic inflammatory disorder that mainly affects the seborrheic region. While ketoconazole is often used, pimecrolimus has been used successfully in SD. OBJECTIVE: To compare the efficacy and tolerability of pimecrolimus in comparison with ketoconazole in the treatment of SD... CONCLUSION: Our study showed that pimecrolimus had a comparable efficacy profile with that of ketoconazole, but side effects appeared more frequently in the pimecrolimus group than in the ketoconazole group.
Comparative efficacy and tolerability of Ketomousse (ketoconazole foam 1%) and ketoconazole cream 2% in the treatment of pityriasis versicolor: results of a prospective, multicentre, randomised study. [2008.11]
Ketomousse (K), a new thermophobic formulation (ketoconazole 1%), has proven its efficacy in the treatment of dandruff, caused by the same agent as pityriasis versicolor (PV). The objective of this study was to compare the efficacy and tolerability of K thermophobic foam vs...
A novel foam formulation of ketoconazole 2% for the treatment of seborrheic dermatitis on multiple body regions. [2007.10]
BACKGROUND: A novel topical foam formulation of ketoconazole has been developed for use on the scalp, body, and face. OBJECTIVE: To evaluate the efficacy and safety of twice-daily treatment with ketoconazole 2% foam for seborrheic dermatitis on the scalp, body, and face... CONCLUSION: Ketoconazole foam 2% is a safe, effective, and versatile formulation for use on the scalp, body, and face for the treatment of seborrheic dermatitis in patients aged 12 years or older.
Comparison between fluconazole and ketoconazole effectivity in the treatment of pityriasis versicolor. [2007.07]
Topical drugs are often effective in limited lesions of pityriasis versicolor; but in extensive cases, systemic drugs are more suitable. Previous studies have shown that ketoconazole and fluconazole are effective in 42-97% and 74-100% of lesions respectively...
Metronidazole 0.75% gel vs. ketoconazole 2% cream in the treatment of facial seborrheic dermatitis: a randomized, double-blind study. [2007.03]
BACKGROUND: Recently, two placebo-controlled studies have shown that topical metronidazole was effective in the treatment of seborrheic dermatitis. OBJECTIVE: To compare the efficacy and safety of metronidazole 0.75% gel with that of ketoconazole 2% cream in the treatment of facial seborrheic dermatitis... CONCLUSION: Our data demonstrated that metronidazole 0.75% gel had a comparable efficacy and safety profile with that of ketoconazole 2% cream in the treatment of facial seborrheic dermatitis.
Clinical Trials Related to Extina (Ketoconazole Topical)
Ketoconazole Foam 2% for the Treatment of Versicolor [Recruiting]
Objectives
1. To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor
2. To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor
based on the occurrence of adverse events.
3. To assess treatment satisfaction as rated by patients
Study Design:
This will be a mono-centered, single arm, open-label pilot study. Ten adult patients age 19
and older with a clinical diagnosis of tinea versicolor, as well as a positive KOH using
calcofluor, will be enrolled at the University of Alabama at Birmingham. There will be 4
scheduled visits (baseline, week 1, week 2, and week 4). A target area will be identified
and mycological and clinical assessments will be performed at this site as well as a global
assessment of each subject. Ketoconazole 2% foam will be applied to all affected areas for 2
weeks with a follow-up visit at week 4. Skin scraping using a disposable #15 blade for
calcofluor/KOH assessment and photographs of target lesions will be performed at baseline,
week 1, week 2, and week 4. Photographs will be taken at baseline and at week 4 (only if KOH
is positive). Body surface area estimation of disease will also be performed at each visit.
Evaluation of scale, hyperpigmentation/erythema, and hypopigmentation using a 4 point scale
(0 = none, 1 = mild, 2 = moderate, 3 = severe) of the target area will be performed at
baseline, week 1, week 2, and week 4. A global assessment will be conducted at each visit
using the same 4 point scale. Patient questionnaires will be administered at baseline and
week 2 to assess symptoms and satisfaction with study medication.
Use of Low Dose Ketoconazole in Prostate Cancer That Does Not Respond to Hormone Therapy and Prior Chemotherapy [Recruiting]
The purpose of this study is to test the safety of ketoconazole and how well it works after
chemotherapy has been used. Ketoconazole at lower doses has been used for fungal infections
however has not yet been approved by the Food and Drug Administration for use in prostate
cancer. Ketoconazole has been used for many years at high doses for prostate cancer, and
this study will be to look at use of lower dose ketoconazole after someone has received
chemotherapy. Ketoconazole works by halting the production of steroids in your body,
including testosterone, and is thought to work directly on prostate cancer cells in
published lab studies.
A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers [Not yet recruiting]
This is an open-label (both the physician and healthy volunteer know which treatment will be
administered) study to assess the pharmacokinetics (process by which JNJ-31001074 is
absorbed, distributed, metabolized, and eliminated by the body) of JNJ-31001074 when taken
alone and in combination with ketoconazole. The study consists of three phases: a
screening phase to determine eligibility, an open-label treatment phase consisting of three
periods and an end-of study/early withdrawal assessment phase.
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer [Recruiting]
The purpose of this study is to test the effectiveness of the experimental drug, 177Lu-J591
in combination with ketoconazole and hydrocortisone against prostate cancer.
Docetaxel Combined With Ketoconazole in Treatment of Breast Cancer [Recruiting]
Patients with locally advanced or metastatic breast cancer and with measurable primary
breast tumor will be treated with 70mg docetaxel combined with ketoconazole. Serial tumor
biopsies and plasma samples will be taken for gene expression and proteomics studies to
identify biomarkers that may predict for treatment response.
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Page last updated: 2009-02-07
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