The purpose of this clinical investigation is to evaluate the effectiveness and safety of Nitrofreeze Skin Tag for the treatment of skin tags versus a comparator device (Scholl Freeze Away® Skin Tag Remover).
The primary objective of the study is to assess the efficacy of Nitrofreeze Skin Tag (tested product) for the treatment of skin tags versus a comparator product. The secondary objectives are to assess the safety of the tested product versus comparator product. To meet these objectives, the subjects will be monitored as follows: At the screening visit (visit 1), the study will be explained to the subject by the investigator before any study related procedures are performed. Both the subject and the investigator will sign the consent form and the investigator will check inclusion and exclusion criteria. This can also be done at the D0 visit. At visit 2 on D0, if the subject is eligible, the subject will perform the first treatment on the selected skin tag with the tested product or comparator, at the lab. At visit 3 on D3, the investigator will evaluate the skin condition on and around the skin tag and collect adverse events. At visit 4 on D15, assessment of effectiveness and safety will be made. A second treatment can be done if first treatment is not effective. Study end if the skin tag was successfully removed. At visit 5 on D30, assessment of effectiveness and safety will be made. A third treatment can be done if second treatment is not effective. Study end if the skin tag was successfully removed. At visit 6 on D45, assessment of effectiveness and safety will be made. Study end. In case of missing treatment on D15 or D30 because of a missing visit or a skin condition that did not permit a new treatment, the third treatment will be done on D45. In that case, a new follow-up visit will be done at D60.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
56
Treatment of the skin tag with NITROFREEZE Skin Tag device on Day 0, Day 15, Day 30.
Treatment of the skin tag with Scholl Freeze Away Skin Tag Remover device on Day 0, Day 15, Day 30.
Eurofins Dermscan Pharmascan
Villeurbanne, France
RECRUITINGCure rate
Comparison of the percentage of subjects having a successful treatment of the selected skin tag in the Nitrofreeze Skin Tag group versus comparator group by clinical evaluation by the blinded evaluator. The investigator, who will be in blind of the treatment administered, will measure the selected skin tag height and diameter in mm before treatment on day 0, day 3, day 15, day 30, day 45 and day 60 if applicable. At each timepoint after first treatment session, the blinded investigator will rate the treatment success using the following scale: 0= No change 1. Improvement 2. Disappearance of skin tag The percentage of subjects having a successful treatment at study end will be calculated for the investigational device and comparator. The treatment is considered successful if the blinded investigator scores the selected skin tag as "2". If the score is evaluated as 0 or 1 at a follow-up visit, a new treatment will be done (maximum 3 treatments).
Time frame: From enrollment to the end of treatment at 60 days (maximum)
Global effectiveness-subjective questionnaire
A subjective evaluation questionnaire, will be filled in by the subjects at study end to evaluate the devices global effectiveness. This questionnaire contains 18 questions concerning effectiveness, where the subjects can score the device with "Agree", "Somewhat Agree", "Neither agree nor disagree", "Disagree" or "Not applicable"
Time frame: Study end (day 15, day 30, day 45 or day 60 according to the treatment success)
Skin condition
Evaluation of the skin condition at each timepoint by clinical evaluation by the blinded investigator. The investigator will evaluate the clinical signs observed on the skin tag and on the healthy skin surrounding the skin tag before treatment on day 0, day 3, day 15, day 30, day 45 and day 60 if applicable using the following clinical scores: * None (0) * Mild (1) * Moderate (2) * Severe (3)
Time frame: From enrollment to the end of the treatment at 60 days (maximum)
Pain during treatment by the subject
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The subjects will be asked to evaluate the pain felt during each treatment on a visual analogic scale of 10 cm.
Time frame: From enrollment to the end of treatment at 60 days (maximum)
Pain and healing process by the subject
The subjects will score every day until next visit in their daily diary the following signs: pain (scale: none, mild, moderate, severe) as well as redness, black colour, blister, wound and scab (scale: absence, presence) in order to evaluate the healing process. The subjects will also be asked to write down any other intolerance reactions that have occurred during the study in the diary.
Time frame: From enrolment to the end of treatment at 60 days (maximum)
Global tolerability
According to the signs observed at each timepoint, the global tolerability of the investigational device and comparator will be defined by the blinded investigator on the following scale at the study end: 0= Bad tolerance: 1. Moderate tolerance 2. Good tolerance 3. Very good tolerance.
Time frame: Study end (Day 15, Day 30, Day 45 or Day 60 according to the treatment success)
Amount and severity of Adverse Events (AEs)
General tolerance by collection of amount and severity of Adverse Events (AEs) by the blinded investigator for the whole study period.
Time frame: From enrolment to the end of treatment at 60 days (maximum)