J Cosmet Dermatol. 2021 Jun 15. doi: 10.1111/jocd.14296. Online ahead of print.
ABSTRACT
BACKGROUND: Lidocaine/tetracaine 7%/7% peel cream (L/T-pC) is very effective in reducing pain in several dermatological procedures, such as hair or tattoo laser removal or conventional photodynamic therapy associated pain. Fractional laser resurfacing (FLR) is an effective treatment strategy for facial skin ageing. The main drawback of FLR is the procedure-associated pain. So far, no controlled data are available regarding the efficacy of L/T-pC in reducing pain during a full facial microablative FLR session in subjects with facial skin ageing.
AIM: To assess the clinical efficacy of L/T-pC in reducing pain during microablative FLR treatment in subjects with facial skin ageing. We conducted a prospective, randomised, parallel-group, controlled, single-blind trial, performed in out-patients attending to a Laser Clinic for facial skin ageing treatment.
SUBJECTS AND METHODS: A total of 30 subjects (4 men, 26 women; mean age 42±10 years; range 28-57) with mild to moderate facial skin ageing (Glogau score ≥2), suitable for FLR treatment, were enrolled after their written informed consent. Participants were randomised to L/T-pC application (45 min before the laser treatment with the removal of the cream just before the starting of laser session) (n=20) or to control (emollient cream; n=10). FLR was performing using a fractional microablative CO2 laser (Smartxide DOT 2 Deka, Calenzano, Italy) using a pulse power of 18 W (range 15-20) and pulse duration of 1.5 msec. The primary endpoint was the comparison of the mean visual-analogue score (VAS) values between the two groups using a 10-cm scale (0= no pain; 10: the most severe pain). The VAS score was measured just after the FLR session. Effective anaesthesia (percentage of subjects with a VAS score ≤3) and the assessment of local tolerability and safety of the peel cream were the secondary trial endpoints.
RESULTS: All the enrolled subjects concluded the trial. In the L/T-pC group the VAS mean score was 3.0±1.2. In the control group the VAS mean score was 8.6±0.5, representing a 65% reduction of the VAS score in the active treated group vs. controls. The difference between the two groups was statistically significant (p=0.0001; Mann-Whitney test) with an absolute difference of -5±0.4 cm; 95%CI of the difference: from -4.6 to -6.4 cm). Adequate anaesthesia (VAS score≤3) was reported in 80% of subjects in the active group vs. 0% in the control arm. The cream was very tolerated. One subject in the active group manifested moderate/severe oedema in the cream application area, subsiding in 6 hours. No other side effects were reported.
CONCLUSION: The application of L/T pC 7%/7% peel cream before a fractional laser resurfacing session significantly reduced the procedure-associated pain with good tolerability and safety profile.
PMID:34129728 | DOI:10.1111/jocd.14296
