Session Item

Patient skin markings are routinely performed for set-up reproducibility. Permanent tattooing is the most popular method, and there are several methods. This study compares two of them: disposable lancets vs. Comfort Marker 2.0® (CM) - a device with a controlled depth tattoo pen. We present the results on comfort, satisfaction, effectiveness, and cosmesis (main trial). Additionally, a substudy was undertaken to assess for cosmesis, fading, and pts satisfaction at 6 months, which results are also presented.

COMFORTATTOO is a prospective, randomized, cohort study. Eligible pts had ≥18 years old, PS of 0-1, and RT schedule ≥13 daily fractions. Pts were randomized in a 1:1 ratio to lancets or CM. Primary endpoints of the main trial were pts comfort (11-point numeric pain scale) and effectiveness (bad, reasonable, good, and excellent); secondary endpoints included RTTs satisfaction with the ease of tattooing (easy, medium, and hard) and cosmesis at the end of RT (tattoo photographs scored by 20 observers on a bad to excellent score). On the substudy, the endpoints evaluated were tattoo fading (tattoo photographs scored by 3 observers on a 5-point scale from no fading to complete fading), cosmesis (same method of main study) and pts satisfaction (10-point scale from completely dissatisfied to completely satisfied), evaluated six months following the end of RT. Allocation was blinded to pts, RTTs in the LINACs, and photographic evaluators.

Between 10/2021 and 01/2022, 100 pts were randomized and assessed for comfort and satisfaction; 98 for effectiveness and the cosmesis. 92 pts were analysed for the substudy between 05/2022 and 10/2022. Baseline characteristics were well balanced. CM was significantly less painful than the lancets, with 44% and 16%, respectively, considering the process painless (RR = 2.75). Pts receiving CM had a significantly higher proportion of markings graded as good and excellent compared to those receiving lancets (98.0% and 50.0%, respectively, had ≥75% of the tattoos assessed as good/excellent, RR = 1.96). On the RTT-reported satisfaction, CM was significantly easier to use compared to lancets (98.0% vs. 78.0% scored easy, respectively; RR = 1.26). On the cosmetic evaluation at the end of RT, pts receiving CM had significantly better cosmetic markings, with a median score of 4.4 (vs. 3.5 for lancets, p <0.001). For the substudy analysis, patients receiving CM had significantly better cosmetic markings at 6 months, with a median score of 4.4 (vs. 3.7 for lancets, p <0.001). The CM was associated with lower scores on the fading assessment compared to the lancets (median score of 1.3 and 3.3, respectively; p <0.001). No difference in pts satisfaction was observed (median score of 10 for both arms, p=0.952).

Tattooing with CM is significantly less painful, more effective, and easier, with better cosmetic outcomes compared to lancets, but with less fading at 6 months. These didn’t translate into pts satisfaction differences.