SINT MAARTEN, NETHERLANDS ANTILLES — New formulations of established oral agents and new combination products are available to treat acne, according to Dr. Hilary Baldwin.
The new oral formulations include extended-release minocycline tablets and delayed-release, enteric-coated doxycycline, she said.
Long-term, yet-to-be published data on extended-release (ER) minocycline tablets (Solodyn) show a low number of adverse events over a 2-year period, Dr. Baldwin said at the Caribbean Dermatology Symposium. The agent does not appear to increase the risk of lupuslike syndrome, a concern some have with minocycline.
No cases of hyperpigmentation occurred among the 136 patients who completed the 2-year study. A total of 13 patients reported nausea and 8 had dizziness or vertigo.
ER minocycline is dosed to 1 mg/kg per day and maintains efficacy despite its lower dose, compared with other minocycline formulations, Dr. Baldwin said. “And food has no impact on absorption of the drug, which is important in our teenage boys who never stop eating.”
Both ER minocycline and delayed-release, enteric-coated doxycycline (Doryx) feature once-a-day dosing that should improve compliance, said Dr. Baldwin of the department of dermatology, State University of New York at Brooklyn.
DR doxycycline is slowly dissolved in the small intestine and features a lower potential for gastrointestinal upset, compared with other formulations of oral doxycycline, Dr. Baldwin said. The agent can be dosed once daily from 37.5 to 200 mg, she added.
In addition to the new oral agents, there is a new topical formulation—solubilized benzoyl peroxide. Solubilization is a chemical process that makes the benzoyl peroxide particle sizes smaller than even currently available micronized formulations. The tiny size and lipophilic and hydrophilic properties of solubilized benzoyl peroxide facilitate increased penetration into the follicle, Dr. Baldwin said. “Other forms of benzoyl peroxide have larger molecules, and you get clumps of [the drug] sitting on the skin.”
Solubilized benzoyl peroxide gel significantly reduced noninflammatory acne lesion counts, compared with a combination of 1% clindamycin and 5% benzoyl peroxide gel, according to a 12-week study by other investigators. There was no significant difference in inflammatory lesion counts between the two groups. The solubilized gel was slightly more irritating, Dr. Baldwin said, with significantly more stinging and burning in the first 4 weeks of treatment.
“The acne toolbox is so darn full the top won't close in 2009,” Dr. Baldwin said. She is a consultant, is an advisory board member, or is on the speakers bureau for Allergan, Galderma, GlaxoSmithKline, Graceway, Medicis, Ortho Neutrogena, Ranbaxy, Sanofi-Aventis, and Stiefel.
The new fixed-dose combination products for combatting acne include clindamycin 1.2%/benzoyl peroxide 2.5% (Acanya) gel, which provides a statistically significant improvement in noninflammatory lesions, compared with placebo, Dr. Baldwin said. This formulation, approved by the Food and Drug Administration in October 2008, allows for a lower strength of the active ingredients, but there are no head-to-head comparisons yet, she said. The “benzoyl peroxide and clindamycin combination prevents an increase in resistance versus clindamycin alone, which did well up to 8 weeks but then resistance increased exponentially.”
According to a 12-month study presented as a poster at the meeting, a fixed-dose combination of adapalene gel 0.1% and benzoyl peroxide 2.5% is a safe and effective topical treatment for acne vulgaris. Dr. David M. Pariser, professor of dermatology at Eastern Virginia Medical School in Norfolk, was the lead author. He reported no relevant disclosures.
In December 2008, the FDA approved the retinoid adapalene and benzoyl peroxide combination (Epiduo gel) for the treatment of acne vulgaris in patients 12 years and older.