NCT07041047

Evaluation of Apaisant Serum - Ingrown Nails for Ingrown Toenails

Open Clinical Investigation to Evaluate Efficacy And Safety of the Medical Device "Apaisant Serum - Ingrown Nails" in The Treatment of Ingrown Nail

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Swiss Footcare Laboratories - Poderm Professional · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Ingrown Toenails
• Ingrown Nail Inflammation

Interventions

Type	Name	Description
DEVICE	APAISANT SERUM - INGROWN NAILS	Topical application of APAISANT SERUM - INGROWN NAILS twice daily for 7 days.

Timeline

• Start date: 2024-06-27
• Primary completion: 2024-08-20
• Completion: 2024-08-20
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

1 site across 1 country: Poland