OBJECTIVE: This study evaluated a unique formulation of lidocaine 4% in an emollient aerosol foam microemulsion system to facilitate rapid delivery of the active ingredient and reduce pain associated with cosmetic dermatologic laser treatment. DESIGN: This was a noncontrolled, open-label, paired, comparison study. SETTING: Private practice dermatology clinic. PARTICIPANTS: Ten patients undergoing various cosmetic laser treatments, 18 years of age or older and considered clinically appropriate for study participation. MEASUREMENTS: Primary endpoints were patient and clinician assessments of procedural pain intensity for the treated and untreated areas. Ratings were recorded on a visual analog scale ranging from "no pain at all" to "the most intense pain imaginable." Secondary study endpoints included clinician and patient subjective assessments of the lidocaine 4% foam. RESULTS:Mean patient and clinician ratings of pain were significantly lower for areas treated with the lidocaine 4% foam compared with pain ratings for untreated areas. No adverse events were reported. Clinician's mean ratings for ease of application and overall satisfaction were favorable. CONCLUSION: The results from this pilot, 10-patient, open-label study suggest that the lidocaine 4% foam may be acceptable to both patients and clinicians for the safe and effective reduction of pain associated with cosmetic dermatologic laser procedures. However, a blinded, placebo-controlled study of a larger population is needed to confirm these preliminary results.
RCT Entities:
OBJECTIVE: This study evaluated a unique formulation of lidocaine 4% in an emollient aerosol foam microemulsion system to facilitate rapid delivery of the active ingredient and reduce pain associated with cosmetic dermatologic laser treatment. DESIGN: This was a noncontrolled, open-label, paired, comparison study. SETTING: Private practice dermatology clinic. PARTICIPANTS: Ten patients undergoing various cosmetic laser treatments, 18 years of age or older and considered clinically appropriate for study participation. MEASUREMENTS: Primary endpoints were patient and clinician assessments of procedural pain intensity for the treated and untreated areas. Ratings were recorded on a visual analog scale ranging from "no pain at all" to "the most intense pain imaginable." Secondary study endpoints included clinician and patient subjective assessments of the lidocaine 4% foam. RESULTS: Mean patient and clinician ratings of pain were significantly lower for areas treated with the lidocaine 4% foam compared with pain ratings for untreated areas. No adverse events were reported. Clinician's mean ratings for ease of application and overall satisfaction were favorable. CONCLUSION: The results from this pilot, 10-patient, open-label study suggest that the lidocaine 4% foam may be acceptable to both patients and clinicians for the safe and effective reduction of pain associated with cosmetic dermatologic laser procedures. However, a blinded, placebo-controlled study of a larger population is needed to confirm these preliminary results.