Evaluation of Apaisant Serum - Ingrown Nails for Ingrown Toenails (NCT07041047) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Apaisant Serum - Ingrown Nails for Ingrown Toenails
Poland22 participantsStarted 2024-06-27
Plain-language summary
To open-label clinical study aims to evaluate the efficacy and safety of APAISANT SERUM - INGROWN NAILS, a Class IIa CE-marked medical device, in relieving pain and discomfort associated with inflamed ingrown nails. The study includes 22 subjects with ingrown nails at stage 1 or 2, who will apply the product twice daily for 7 days. The primary objective is to assess the reduction of pain using a Numerical Rating Scale (NRS, 0-10). Secondary objectives include assessing discomfort, inflammation, and overall symptom improvement. The study also evaluates investigator and patient global assessments, tolerance, and acceptability of the product. Safety will be monitored through clinical assessments and the collection of adverse events.
Who can participate
Age range3 Years
SexALL
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Inclusion Criteria:
* 1\. Patient having given her/his informed, written consent. 2. Patient cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected.
3\. Patient being psychologically able to understand information and to give their/his/her consent.
4\. Male or female more than 3 years old. 5. Minor whose legally designated representative have given their free and express informed consent.
6\. Subject affiliated to a health social security system. 7. Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end.
8\. Subjects presenting an inflamed Ingrown nails (folds) and with pain ;.
* state 1 : inlaid nail OR
* state 2 : peri inguale inflammation
Exclusion Criteria:
* 1\. Subject presenting state 3 or 4 of the ingrown nails (presenting wounds, bleeding, discharge, granulation tissue growth).
2\. Subject who is currently participating, in another clinical study liable to interfere with the study assessments according to the investigator's assessment 3. Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing or to report required information in writing in his/her diary 4. Subject who, in the judgement of the investigator, is no…
What they're measuring
1
Change in pain severity of the ingrown toenail
Timeframe: Day 7 (D7) compared to baseline (D0)
Trial details
NCT IDNCT07041047
SponsorSwiss Footcare Laboratories - Poderm Professional