PRAGUE – A novel self-occlusive topical anesthetic cream newly approved by the Food and Drug Administration for local analgesia in superficial dermatologic procedures displayed persuasive evidence of efficacy in a phase III study highlighted at the annual congress of the European Academy of Dermatology and Venereology.
The topical anesthetic cream, called Pliaglis, incorporates lidocaine and tetracaine at 70 mg/g each. The FDA approved the product in October 2012 for use in conjunction with filler injections, laser-assisted tattoo removal, pulsed dye laser therapy, and other dermatologic procedures.
At the congress, Y. May Ma, Ph.D., presented the results of a multicenter phase III clinical trial involving 50 patients undergoing laser-assisted hair removal. Investigators applied Pliaglis to half of the skin surface scheduled for treatment and a placebo cream to the other half. Thirty minutes later dermatologists peeled off both materials and got to work.
Participants’ mean pain score for the laser procedure on a 0-100 visual analog scale was 23 for the Pliaglis-pretreated areas compared with 32 for hair removal on the control areas. Eighty percent of patients rated the analgesic effect as adequate on Pliaglis-pretreated skin areas, but only 52% did so for placebo-pretreated areas, reported Dr. Ma of Galderma Laboratories in Sophia Antipolis, France.
Blinded investigators rated 44% of patients as having no pain during laser therapy on areas that had been pretreated with Pliaglis, compared with an investigator-judged 22% pain-free procedure rate on placebo-pretreated areas.
Mild, transient stinging, redness, and erythema were fairly common on Pliaglis-treated skin, but quickly resolved without any intervention, Dr. Ma observed.
This study was funded by Galderma and presented by a full-time Galderma employee.