Company:
Barrier Therapeutics
Pharmacologic class:
Topical antifungal (azole)
Active ingredient:
Ketoconazole 2%; topical gel (anhydrous).
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Indication:
Topical treatment of seborrheic dermatitis in immunocompetent patients.
Pharmacology:
Seborrheic dermatitis is a chronic inflammatory skin disorder that is characterized by a red, itchy, scaly rash typically occurring on the face, scalp, hairline, and trunk.
Ketoconazole acts by inhibiting the cell-membrane synthesis of susceptible fungal organisms. Although not established conclusively, the mechanism of action of topically applied ketoconazole in the treatment of seborrheic dermatitis may be due to its antifungal activity against Pityrosporum ovale (also known as Malassezia furfur). The safety and efficacy of Xolegel for the treatment of fungal infections have not been established.
Following topical application of Xolegel, plasma levels of ketoconazole are far less than those typically seen with orally administered ketoconazole.
Xolegel is for topical use only and not for ophthalmic, oral or intravaginal use. If irritation occurs or if the disease worsens, use of the medication should be discontinued.
This product is flammable so patients should avoid fire, flame, or smoking during and immediately following application of Xolegel.
Clinical trials:
In a clinical study designed to assess the safety and effectiveness of Xolegel, 459 patients with moderate-to-severe seborrheic dermatitis were treated with either this product or a vehicle control. In this randomized, double-blind, multicenter study, patients were treated once daily for 14 days and efficacy was assessed at Day 28. Effective treatment was defined as the Investigator’s Global Assessment Score of ≤ 1 as “completely clear” or “almost clear.”
The treatment was also defined by the erythema and scaling scores reduced to 0 (none) for patients whose baseline scores were 2 and reduced to 1 (mild) for those whose baseline scores were 3. Two weeks after treatment was completed, 25.3% of patients using Xolegel were determined to be “effectively treated” compared with 13.9% for those using vehicle only.
Two other randomized, double-blinded, vehicle-controlled, multicenter, parallel-group studies enrolling 316 patients were completed. These studies support the efficacy of Xolegel for seborrheic dermatitis as a once-daily dose for 14 days. Efficacy was also assessed by the proportion of patients who were completely clear at Day 28.
Adults:
Apply a thin layer to affected area(s) once daily for two weeks. Wash hands before and after use. Do not wash treated areas for at least three hours after application. Wait at least 20 minutes before applying cosmetics, sunscreen, etc.
Children:
<12 years: not recommended.
Precautions:
Avoid eyes, lips, mucous membranes. If irritation occurs or if disease worsens, then the use of the medication should be discontinued. Product is flammable (avoid open flames, smoking while applying). Pregnancy (Cat. C). Nursing mothers.
Adverse reactions:
Application site burning, headache.
How supplied:
Gel—15g.
For more information, call 866.440.5508 or visit www.Xolegel.com.
