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The study was set up to have one unblinded observer, the patient and a blinded observer studying the patient’s skin at every visit.
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.
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 Dermatology 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."