Levulan

New Orleans -- With an increasing number of anecdotal reports, Jeffrey Dover, M.D., director of SkinCare Physicians of Chestnut Hill, Mass., demonstrated that adjunctive use of topical aminolevulinic acid (5-ALA) with intense pulsed light (IPL) is beneficial in treating photoaging.

Dr. Dover presented, "Adjunctive use of topical 5-ALA with IPL in the treatment of photoaging" at the 63rd Annual Meeting of the American Academy of Dermatology here.

His fellow authors in the study were Drs. Ashish Bhatia, Kenneth Arndt and Brigitte Stewart.

"We proposed and got funding from DUSA, the company that makes Levulan, to perform a split face study comparing IPL on one side of the face to 5-ALA preceding IPL on the other side of the face" Dr. Dover says. "We treated 20 individuals who each had a total of five treatments; the first three treatments on one side were 5-ALA plus IPL and the other side IPL alone. The last two treatments were just straight IPL to both sides of the face. They were done monthly, (for a) total of five treatments and 20 subjects."

Study results

The study was set up to have one unblinded observer, the patient and a blinded observer studying the patient's skin at every visit. Both the patient and the blinded observer found that global photodamage, blotchy brown pigmentation and fine lines improved with the differences on the IPL/5-ALA side statistically significantly greater than IPL side alone.

"We also found that the combination of 5-ALA and IPL improved sallowness and tactile roughness, but there was no statistical difference in the degree of improvement between the two sides," he continues. "In general, the IPL and IPL/5-ALA sides improved all five items we looked at including global photoaging, fine lines, brown pigmentation sallowness and tactile roughness. There was statistically significant increased improvement on the 5-ALA/IPL side in fine lines, brown pigmentation and global photoaging, which was about 35 percent greater improvement on the combined side. These were all significant with p values less than .02, very significant differences. Also, given the fact that we had 100 percent patient compliance these are very powerful numbers."

Another aspect of the results that Dr. Dover found fascinating is that, in general, IPL photorejuvenation alone has not been shown to help fine lines and, if so, very minimally. However, in this study they demonstrated a 20 percent improvement in fine lines on the IPL side alone and a 55 percent improvement on the combined side (IPL plus 5-ALA). They also demonstrated about a 35 percent difference in improvement in global photoaging and brown pigmentation, an improvement that approached 90 percent on the combined side and between 60 percent to 65 percent on the IPL side alone.

Compliance key factor

In determining the efficacy and safety of this combination approach, patient compliance not only demonstrated the addition of 5-ALA to IPL to be effective but it also demonstrated the limited extent of adverse reactions.

"Overall, 100 percent of the patients complied and completed every single one of the visits; there were a total of over 180 visits," Dr. Dover says. "It is very unusual in clinical studies to have 100 percent of patients complete the trial; usually there is a 15 percent to 20 percent dropout rate at least."

If the combination of 5-ALA plus IPL had produced more side effects, (significantly more side effects than IPL alone), Dr. Dover says that there would have been a much higher dropout rate.

"We had a dropout rate of basically zero, which suggests that we had a very good study coordinator throughout this trial, the treatment must have been working and the side effects on one side could not have been a lot more than on the other side, otherwise people would have dropped out" Dr. Dover tells Cosmetic Surgery Times. "It is also fair to say that people were seeing relatively good results on both sides and were not getting way better clearing on one side, otherwise they would have gotten upset and dropped out"

In terms of side effects, Dr. Dover says that there was a bit more redness and edema on the IPL/5-ALA side than on the IPL-alone side and that these adverse reactions were statistically significant but only lasted for a few days and did not interfere with daily life. Although these results were statistically significant, they were uncommon events and very mild events.

"Overall, the take-home message from a practical point of view is that this is the first controlled split-face study to demonstrate conclusively that adding 5-ALA to IPL makes IPL photorejuvenation a better treatment," Dr. Dover says. "It improves all five characteristics we looked at, and three of them were dramatically better including fine lines, photoaging and brown pigmentation. This is practical in a clinical situation because the numbers of side effects on the combined side were very few and very mild."

Precautions to take

"I think if dermatologists are going to consider 5-ALA/IPL photorejuvenation in practice, our suggestion is that they have their patients practice strict sun avoidance for 36 hours after treatment and they will get nice results and very few side effects," Dr. Dover says. "We had our patients practice strict sun avoidance and as a result, we had very few side effects. If the people had just gone driving home and hung around and did their normal activities we would have had way more side effects on the combined side. Some physicians allow their patients to have ambient sun exposure and light exposure after treatment to maximize improvement with each treatment, but they get way more redness, way more edema and much more discomfort."

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