Xolegel for treating seborrheic dermatitis (seb derm)

Although this poster session doesn’t name Xolegel (poster sessions aren’t supposed to name products directly) as the product that was studied, it looks likely that this is the product as the company involved, Barrier Therapeutics has recently gained FDA approval for Xolegel (also known as sebazole).

Anti-inflammatory effects of ketoconazole: Clinical benefits in the treatment of seborrheic dermatitis, Lieve Vandeplassche, Barrier Therapeutics, Princeton, NJ, United States

Seborrheic dermatitis is a common inflammatory skin disorder characterized by a red, scaly, itchy rash on the scalp, face, and trunk. Topical ketoconazole has been in the armamentarium for the treatment of seborrheic dermatitis for decades. Topical ketoconazole formulations have demonstrated efficacy in clinical trials, and therapeutic benefits were attributed to its reduction in the number of Malassezia furfur (Pityrosporum ovale) cells. It was believed that this antimycotic effect was responsible for the reduced inflammation observed in patients with seborrheic dermatitis who received treatment. While this mechanism of action is sound, additional possible mechanisms have emerged. In a murine gene activation study, ketoconazole reduced LPS-induced increase in enzyme iNOS mRNA activation by ~50%. This reduction in gene expression and consequent inhibition of reactive radical nitric oxide production supports another mechanism for the anti-inflammatory effect of ketoconazole. This may explain the antierythema and antiedema action of the compound. A study in test animals found that topical ketoconazole had anti nflammatory activity against the erythema and hyperkeratosis induced by the application of killed Staphylococcus aureus and was comparable to the effects of steroid therapy.

Recent findings are also being evaluated which may further demonstrate the anti inflammatory properties of ketoconazole. Specifically, data on ketoconazole USP 2% gel, a novel formulation that utilizes a unique transdermal delivery medium appears to support such activity. A double-blind study evaluating cumulative irritation potential over a 21-day period found that ketoconazole USP 2% gel was less irritating than its topical gel vehicle. In a separate supportive phase 3 study ketoconazole USP 2% gel provided comparable improvement in signs and symptoms scores to a combination of ketoconazole and the steroid desonide in the treatment of seborrheic dermatitis. In conclusion, the efficacy of ketoconazole may be supported by its anti inflammatory properties, a key factor in the treatment of seborrheic dermatitis. These anti inflammatory effects have been attributed to the antimycotic activity of ketoconazole, but growing data suggest that other mechanisms may also be responsible.

100% is sponsored by Barrier Therapeutics.

Poster Abstract P807, American Academy of Dermatology, 65th Annual Meeting February 2-6, 2007, Washington, DC. Published in Journal of the American Academy of Dermatology Volume 56, Number 2.

Further Reading ;

• product web site for Xolegel and the Xolegel Prescribing Information
• sebazole (topical ketoconazole gel 2%) low systemic absorption for short treament periods
• topical 2% ketoconazole warnings for long term usage
• itraconazole and treating seb derm
• seb derm, elidel and protopic : a warning
• Seborrheic Dermatitis ketoconazole nizoral shampoo

Read more about: seborrheic dermatitis