XOLEGEL SUMMARY
XOLEGELTM (KETOCONAZOLE, USP) GEL, 2%
Rx ONLY
FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
XOLEGEL Gel contains the antifungal agent ketoconazole USP at 2% in a topical anhydrous gel vehicle.
XOLEGEL Gel is indicated for the topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older.
Safety and efficacy of XOLEGEL Gel for treatment of fungal infections have not been established.
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NEWS HIGHLIGHTSMedia Articles Related to Xolegel (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 Xolegel (Ketoconazole Topical)
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.
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.
Ocular pharmacokinetics of topically-applied ketoconazole solution containing hydroxypropyl beta-cyclodextrin to rabbits. [2008.10]
PURPOSE: The aim of this study was to develop an aqueous ketoconazole (KET) eye drop in order to increase the corneal permeability and improve ocular bioavailability following topical application. METHODS: Hydroxypropyl beta-cyclodextrin (HP-beta-CD) was used to formulate an aqueous eye drop to improve the aqueous solubility of KET...
An open, randomized, prospective, comparative study of topical pimecrolimus 1% cream and topical ketoconazole 2% cream in the treatment of seborrheic dermatitis. [2008.08.01]
Background: Seborrheic dermatitis (SD) is a chronic inflammatory disorder that mainly affects the seborrheic region... 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.
Clinical Trials Related to Xolegel (Ketoconazole Topical)
A Study to Assess the Safety and Interaction Between Casopitant and Ketoconazole When Taken By Healthy Adults [Completed]
Ixabepilone and Ketoconazole in Treating Patients With Advanced Solid Tumors [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy, such as ixabepilone and ketoconazole, work in
different ways to stop tumor cells from dividing so they stop growing or die. Giving
ixabepilone with ketoconazole may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving
ixabepilone together with ketoconazole and to see how well they work in treating patients
with advanced solid tumors.
Study Of Healthy Subjects To Assess The Effect Of Ketoconazole And The Way The Body Will React To Casopitant [GW679769] [Completed]
This is a two period study of healthy adult subjects to characterize the effect of the dosing
of ketoconazole on the the way the body reacts to a dose of GW679769, and to assess the
safety profile of oral casopitant with and without ketoconazole. This study will consist of a
screening period, two treatment periods and a post-treatment follow-up visit.
Long Term Study of Extina in Patients With Seborrheic Dermatitis [Recruiting]
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.
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.
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Page last updated: 2009-02-08
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