Efficacy Evaluation of the Pixie(®) Skin Tag Cryogenic Device on Skin Tags in a Prospective, Single-Blinded, Randomized, Comparative Clinical Trial

INTRODUCTION: Cryotherapy is an efficient method to treat various cutaneous lesions. In the current clinical evaluation, the efficacy of the Pixie(®) Skin Tag cryogenic pen as a home treatment for benign skin tags was evaluated against a marketed comparator device. In addition, the safety, tolerability, and expected visual effects of the treatment were assessed. METHODS: Fifty-six healthy volunteers presenting with skin tags were included and randomized in a prospective, single-blinded, parallel, single-center, comparative trial and subjected to treatment with either Pixie(®) Skin Tag or a comparator device, Wortie(®) skin tag remover. Selected skin tags located on the neck, breast, and under the armpits were topically treated according to device prescriptions for maximally three times with a 15-day interval between treatments. RESULTS: Of the skin tags treated with Pixie(®) Skin Tag, 64.3% completely disappeared during the study, of which half of the skin tags were cleared after one treatment, compared with 7.1% of the study population treated with Wortie(®) skin tag remover (p < 0.001). Both medical devices were safe to use, painless, and very well tolerated by 64.3% in the Pixie(®) Skin Tag and 96.4% in the Wortie(®) skin tag remover group. In addition, 72% of the subjects using Pixie(®) Skin Tag were satisfied with the results, and two-thirds of this study group would buy and use the device for the treatment of other skin tags. For the comparator device, only 11.0% were satisfied and 7.0% would buy the device. CONCLUSION: Treatment of skin tags with Pixie(®) Skin Tag showed superior clinical performance when compared to Wortie(®) skin tag remover. Both treatments were safe and well tolerated, with the majority of skin response serving as a predictor for clinical performance in the Pixie(®) Skin Tag treated group. TRIAL REGISTRATION NUMBER: ANSL Registration: 2018-A01804-51.