MAUI, HAWAII A topical trolamine/sodium alginate emulsion resulted in significantly faster healing than topical antibiotics after a variety of common procedures without promoting bacterial resistance or causing contact dermatitis, according to Dr. Leon H. Kircik.

"We can utilize it in most of the simple procedures we perform every day: shave biopsies, cryosurgery, topical [5-fluorouracil], Mohs surgery. I think your patients will welcome having to wear a Band-Aid on their face for a couple days less," he said at the annual Hawaii dermatology seminar sponsored by Skin Disease Education Foundation.

Dr. Kircik conducted an investigator-blinded randomized trial comparing twice-daily Biafine (trolamine/sodium alginate emulsion, Ortho-McNeil Pharmaceuticals Inc.) with twice-daily Polysporin ointment (bacitracin zinc and polymyxin B sulfate, Pfizer Inc.) for second-intention healing following Mohs micrographic surgery for nonmelanoma skin cancers on the face of 25 patients.

The Biafine-treated wound sites healed significantly faster. Mean wound size decreased from 112 mm₂ at baseline to 22.1 mm₂ at week 3 with complete healing in all patients by week 6. In contrast, the topical antibiotic-treated wounds averaged 102 mm₂ at baseline, 28.9 mm₂ at week 3, and 3.8 mm₂ at week 6. Two patients in the topical antibiotic group rated their wound treatment as ineffective at week 3.

The 13 patients in the Biafine arm were assessed as having significantly less erythema, erosion, and inflammation at week 3 than the 12 patients in the topical antibiotic arm.

Dr. Kircik has shown that Biafine speeded healing of shave biopsy sites among 15 patients in another study, and he also found that Biafine outperformed white petrolatum in reducing the marked skin irritation caused by 5-FU therapy for actinic keratoses in a 23-patient investigator-blinded trial. In none of his studies did a single Biafine-treated patient develop contact dermatitis.

Dr. Kircik noted that Dr. James Q. Del Rosso of the University of Nevada, Las Vegas, has shown in a randomized investigator-blinded trial that Biafine resulted in significantly faster healing of multiple cryotherapy-treated actinic keratoses than did a nonmedicated petrolatum-based ointment.

Biafine-treated sites on the dorsal hands were completely healed in a mean of 9 days, compared with 11 days in the control group in Dr. Del Rosso's study. Lesions on the dorsal forearms healed in 10 days with Biafine and 13 days with petrolatum. Those on the cheek healed completely in 9 days with Biafine, versus 11 days with petrolatum, and lesions on the forehead healed in 9 days with Biafine, compared with 13 days with petrolatum.

"You may say, '2 days, 3 days, what's the big deal?' But if you look back at the Valtrex [valacyclovir] trials for herpes simplex, the improvement in healing time was around a day, sometimes less. So, really, if you're helping your patients heal 2 or 3 days faster it's a big advantage for them," said Dr. Kircik, who is in private practice in Louisville, Ky., and is a member of the faculty at Indiana University, Indianapolis.

Biafine is widely used in Europe for the treatment of radiation dermatitis, which occurs in close to 90% of women undergoing radiation therapy for breast cancer. The skin complication usually begins in the third week of radiotherapy and peaks a week or two after the course of radiation is completed.

The progression is from erythema to inflammation to desquamationa grade 3 complicationto skin necrosis and ulceration. Biafine has been shown to reduce the rate of progression to grade 3/4 toxicity, enabling patients to complete their cancer treatment without delays.

"The bottom line is radiation dermatitis is really not a dermatitis. It becomes a complex open wound at grades 3 and 4, and it has to be treated like an open woundand that's where this topical agent comes into play," Dr. Kircik said.

Biafine is approved in the United States as a prescription medical device. In vitro studies have shown that trolamine/sodium alginate induces a 3- to 10-fold increase in macrophage proliferation. The macrophages, in turn, stimulate fibroblasts to promote epithelial cell multiplication and growth. The product contains demineralized water, which penetrates to the dermal layer within 1 hour of application, he explained.

Dr. Kircik uses Biafine routinely in numerous situations he encounters in daily clinical practice. "I'm really trying to get away from using topical antibiotics because of all we hear about bacterial resistance, and also the contact dermatitis problem," he said in an interview.

Dr. Kircik disclosed that he is a consultant to, and on the speakers bureau of, OrthoNeutrogena, which markets Biafine and is a division of Ortho-McNeil.

SDEF and this newspaper are owned by Elsevier.

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Healing progression of a topical trolamine/sodium alginate emulsion-treated wound on a patient's left clavicle is shown from baseline to 1 month. PHOTOS COURTESY DR. LEON H. KIRCIK

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Biafine Speeds Healing of Mohs-Related Surgery Wounds