Biafine noncomedogenic: Emulsion promotes healing by recruiting macrophages

Key Points

Washington - A topical emulsion containing trolamine and sodium alginate (Biafine, OrthoNeutrogena) - approved fairly recently by the Food and Drug Administration (FDA) - has proven to be noncomedogenic, according to a small study.

Available in France for more than 25 years, Biafine earned FDA approval as a 510(k) device in 2006. Its indications include superficial and full-thickness wounds, pressure sores, dermal ulcers, first- and second-degree burns, radiation dermatitis and minor abrasions, its manufacturer says.

The product moreover promotes healing of damaged skin by recruiting macrophages (Coulomb B, Friteau I, Dubertret I. Skin Pharmacol. 1997;10:281-287).

Shortly after its U.S. approval, she says, "Many people were using the product after surgical procedures on their faces such as peels and laser treatments.

"Because no one would want to get comedone formation after they've just had their beautiful new skin revealed, we wanted to make sure that Biafine was noncomedogenic."

Study details

For the study, researchers recruited 15 healthy adult volunteers (ages 18 to 45 years) and applied the product to their upper backs, in areas where pores were clearly visible, a total of 12 times at 48- to 72-hour intervals under occlusive patches, Ms. Nighland says.

To serve as a negative control, researchers applied undosed occlusive patches to separate sites, which were randomized on a rotating basis for each patient.

Researchers then graded patch sites for irritation using the North American Contact Dermatitis Group rating scale.

At the study's end, they also took follicular biopsies and examined the number and size of microcomedones present at each site.

Investigators graded microcomedone formation using the following global assessment scale: zero (no microcomedones), 0.5 (slight/1 percent to 24 percent smallish horny masses), one (slight/25 percent to 49 percent smallish horny masses), two (moderate/50 percent to 74 percent moderately sized horny masses) and three (severe/75 percent to 100 percent larger globoid microcomedones).

Researchers compared global assessment data for test and control sites, seeking statistically significant differences (P ≤ 0.05) using an analysis of variance (ANOVA) with pairwise comparisons (Fischer's least significant difference). Researchers considered samples with mean comedogenicity scores of one or more that were statistically greater than the mean value for negative control sites to be positive for comedogenicity, Ms. Nighland says.

Fourteen subjects - 13 female and one male - completed the study. Most were Caucasian, and their mean age was 34 years.

However, researchers did not perform a follicular biopsy on one subject who experienced overall irritation at the site of trolamine and sodium alginate occlusion, Ms. Nighland says.

The active treatment posted a mean comedogenicity score of 0.65, versus 0.79 for the negative control. However, the difference between these comedogenicity scores was not statistically significant (P ≤ 0.05).

Researchers, therefore, concluded that physicians and patients can use the trolamine/sodium alginate emulsion to treat wounded skin without clinical concern for comedogenicity.

When asked if there was anything surprising in the study's results, Ms. Nighland says, "Absolutely not."

Disclosure: Johnson & Johnson Consumer & Personal Products Worldwide fully sponsored this study.

For more information: http://www.aad.org/ http://www.cpcus.jnj.com/