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.
Keywords: Cryotherapy; Efficacy; Home treatment; Nitrous oxide; Pixie® Skin Tag; Prescription-free; Skin tags; Tolerability.