Open Clinical Investigation to Evaluate Efficacy And Safety of the Medical Device "Apaisant Serum - Ingrown Nails" in The Treatment of Ingrown Nail
Open Clinical Investigation to Evaluate Efficacy And Safety of the Medical Device "Apaisant Serum - Ingrown Nails" in The Treatment of Ingrown Nail
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.
This open-label, before-and-after study aims to assess the efficacy and tolerance of APAISANT SERUM - INGROWN NAILS in relieving pain, discomfort, and inflammation associated with ingrown toenails (stage 1 and 2). The study will include 22 subjects, ensuring a minimum of 20 analyzable cases. Participants will apply the product twice daily for 7 days at home.
Primary Objective:
To evaluate the reduction in pain at Day 7 (Visit 2) compared to baseline (Day 0), using a 0-10 Numerical Rating Scale (NRS).
Secondary Objectives:
To assess the reduction of discomfort at Day 7. To evaluate improvement in clinical symptoms (redness, edema, inflammation) and subjective symptoms (pain while touching, irritation).
To track daily pain and discomfort reduction from Day 1 to Day 7 compared to baseline.
To conduct Investigator Global Assessment (IGA) and Patient Global Assessment (PGA) at Day 7.
To assess subjective product acceptability, efficacy, and tolerance using a questionnaire.
To evaluate safety through clinical assessments, investigator evaluations, and monitoring of adverse events.
Study Design:
Participants will be enrolled based on inclusion and exclusion criteria, ensuring that subjects with stage 3 or 4 ingrown nails (with wounds, bleeding, or granulation tissue) are excluded. Data will be collected via investigator assessments and subject-reported outcomes.
Endpoints:
Primary Endpoint: Change in pain score after 7 days of treatment. Secondary Endpoints: Changes in discomfort, symptom improvement, pain/discomfort trajectory from Day 1 to Day 7, IGA, PGA, product tolerance, and safety (including adverse events).
Product Information:
Reference/Name: APAISANT SERUM - INGROWN NAILS Class: Class IIa CE-marked medical device Form: Liquid Dosage: Twice daily Duration: 7 days Administration Route: Topical application
Randomization and Blinding:
Not applicable; the study is open-label, with neither the investigator nor the subjects blinded to treatment.
Study Duration per Subject:
7 days The study aims to provide clinical evidence supporting the efficacy and tolerance of APAISANT SERUM - INGROWN NAILS in alleviating pain and discomfort from ingrown nails.
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 not likely to be compliant with study-related constraints and requirements 5. Subject who has forfeited his/her freedom by administrative or legal award or is under guardianship 6. For woman of childbearing potential: pregnant or breastfeeding or planning to get pregnant during the study 7. Subject having a skin disease, skin abnormalities, or dermatological condition on the studied area liable to interfere with the study assessments 8. Subject with a known history of allergy or contact dermatitis caused by any of the ingredients of the tested product 9. Acute, chronic or progressive disease or medical history considered by the investigator hazardous for the subject or incompatible with the study or liable to interfere with the study assessments 10. Any systemic treatment incompatible with the study or liable to interfere with the study assessments according to the investigator, in the weeks prior to the inclusion visit, ongoing or planned to be started during the study 11. Any topical treatment on the tested area incompatible with the study or liable to interfere with the study assessments according to the investigator, in the weeks prior to the inclusion visit, ongoing or planned to be started during the study.