Health TrialsbyHealthPanel

Evaluate the Effectiveness and Safety of a Cryogenic Pen to Treat Skin Tags Versus a Comparator.

ConditionSkin Tags
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorOystershell NV

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Healthy subject.

Sex: male or female.

Age: more than 22 years old.

Phototype: I to III according to Fitzpatrick.

Disqualifiers

Pregnant or nursing woman or planning a pregnancy during the study.

Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.

Subject in a social or sanitary establishment.

Subject having received 6000 euros indemnities for participation in clinical research in the 12 previous months, including participation in the present study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • NITROFREEZE Skin tag

    Device

    Treatment of the skin tag with NITROFREEZE Skin Tag device on Day 0, Day 15, Day 30.

  • Scholl Freeze Away Skin Tag Remover

    Device

    Treatment of the skin tag with Scholl Freeze Away Skin Tag Remover device on Day 0, Day 15, Day 30.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: NITROFREEZE SKIN TAGExperimental treatment 1 intervention
Group B: Scholl Freeze Away Skin Tag RemoverActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cure 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)

Secondary outcomes

1

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)
2

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)
3

Pain during treatment by the subject

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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oystershell NV

Lead sponsor

Eurofins Dermscan Pharmascan

Collaborator

Source ClinicalTrials.gov
Apply now