Tweaking Fraxel protocol might reduce PIH disease

October 1, 2007

A Brazilian study supports the safety and efficacy of fractional resurfacing as a treatment for recalcitrant melasma, says its lead investigator, who also suggests a new protocol might lower the risk of postoperative PIH.

Key Points

National report - Fractional laser resurfacing doesn't prevent melasma recurrences, but it safely offers the possibility of significant improvement for recalcitrant melasma, according to a recent study.

Its authors suggest that with the device used, lowering standard treatment density while increasing intensity lowers patients' risk of postinflammatory hyperpigmentation (PIH).

Researchers enrolled 50 Brazilian patients (49 female, aged 27 to 50 years) with Fitzpatrick skin types II through V who had melasma that showed minimal improvement after multiple courses of bleaching agents and chemical peels. One hour before treatment, researchers applied topical anesthetic gel (lidocaine 23 percent, tetracaine 7 percent) to treatment areas, which included the forehead, cheeks and chin. They also used a standard blue dye to delineate treatment areas and serve as a guide for the intelligent optical tracking device of the laser handpiece (Fraxel SR, Reliant Technologies).

Dr. Sakamoto is a dermatologist working on a Ph.D. in dermatology from the Federal University of São Paulo-Escola Paulista de Medicina in conjunction with the Wellman Center for PhotoMedicine, Massachusetts General Hospital and Harvard Medical School.

"Contrary to the equipment company's suggestion," she tells Dermatology Times, "no overlap was performed immediately after each pass. In Brazil, most of our patients had darker skin, and overlapping would have delivered more heat to the skin," which would have induced more inflammation and PIH. Investigators also used a hand-held cooling device (Cryo 5, Zimmer) to cool the skin during all treatments, and instructed patients to use sunscreens and topical steroids after treatment, Dr. Sakamoto says.

Study analysis

To evaluate results, patients and three dermatologists analyzed digital photographs (with Mirror Dermagraphix Body Mapping Software v 7.0, Canfield Imaging Systems) taken before treatment, immediately afterward and at various intervals for up to 12 months thereafter. They assigned standardized grades as follows: 0 = no response or worsening, 1 through 4 = improvements of up to 25 percent, 26 to 50 percent, 51 to 75 percent, or at least 76 percent, respectively.

Overall, more than one-third of patients achieved more than 50 percent clearance and reported high satisfaction levels, Dr. Sakamoto says. Specifically, the proportion of patients who fell into each category was: grade 0 (6 percent), 1 (32 percent), 2 (34 percent), 3 (24 percent) and 4 (10 percent).

"Physicians and patients agreed that 90 percent of the patients who achieved grade 3 or 4 at the end of the treatment showed considerable improvement after the first session," Dr. Sakamoto says.

Generally, she says, "Patients who had more treatment sessions had better results." However, no patient achieved 100 percent clearance.

As for adverse events, 60 percent of subjects reported moderate pain, while PIH occurred in a total of three patients (two with type III skin, one with type IV) and resolved after four to eight weeks' treatment with topical bleaching agents, Dr. Sakamoto says.

Unexpected results

During the follow-up period, three patients who had initially achieved significant improvement after two to three treatments experienced worsening of their melasma, she adds.

"We never expected worsening of the melasma, especially after months of treatment," Dr. Sakamoto says. In two of these patients, she says, "We were able to establish a direct relationship between the worsening event and sun exposure."

Similarly, she says four patients experienced recurrences during Brazil's summer, although researchers observed no hypopigmentation at any point during the study.