Evaluation of Apaisant Serum - Ingrown Nails for Ingrown Toenails

NCT07041047 | Completed

• 1 other identifier: 23E2009
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ingrown Toenails; Ingrown Nail Inflammation

Keywords

Ingrown nails; Ingrown toenails treatment; Pain relief; Topical treatment; Medical device; Nail inflammation; Clinical study on ingrown nails

Outcome Measures

Primary Outcomes (1)

• Change in pain severity of the ingrown toenail

  Pain severity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate a worse outcome. The primary objective is to determine the effectiveness of Apaisant Serum - Ingrown Nails in reducing pain after 7 days of treatment.

  Day 7 (D7) compared to baseline (D0)

Secondary Outcomes (20)

• Change in discomfort severity of the ingrown toenail

  Day 7 (D7) compared to baseline (D0)

• Improvement in ingrown nail symptom - redness

  Day 7 (D7) compared to baseline (D0)

• Improvement in ingrown nail symptom - edema

  Day 7 (D7) compared to baseline (D0)

• Improvement in ingrown nail symptoms - inflammation

  Day 7 (D7) compared to baseline (D0)

• Improvement in ingrown nail symptoms - pain touch

  Day 7 (D7) compared to baseline (D0)

Study Arms (1)

Evaluation of Apaisant Serum - Ingrown nails for Ingrown Toenails

EXPERIMENTAL

Subjects in this arm applied APAISANT SERUM - INGROWN NAILS topically to the affected nail area twice daily for 7 days. The serum provides a dual mechanical action: (1) lubrication of the nail plate with a lipid film to reduce friction with periungual tissue and (2) hydration of the nail to improve flexibility and prevent further irritation. The study was conducted as an open-label, before-and-after investigation, assessing changes in pain, discomfort, and clinical symptoms associated with ingrown toenails.

Device: APAISANT SERUM - INGROWN NAILS

Interventions

APAISANT SERUM - INGROWN NAILS DEVICE

Topical application of APAISANT SERUM - INGROWN NAILS twice daily for 7 days.

Evaluation of Apaisant Serum - Ingrown nails for Ingrown Toenails

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Patient being psychologically able to understand information and to give their/his/her consent.
• \. Male or female more than 3 years old. 5. Minor whose legally designated representative have given their free and express informed consent.
• \. 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.
• \. Subjects presenting an inflamed Ingrown nails (folds) and with pain ;.
• state 1 : inlaid nail OR
• state 2 : peri inguale inflammation

You may not qualify if:

• \. Subject presenting state 3 or 4 of the ingrown nails (presenting wounds, bleeding, discharge, granulation tissue growth).

Sponsors & Collaborators

• Swiss Footcare Laboratories - Poderm Professional: lead

Study Sites (1)

Eurofins Dermscan Poland

Gdansk, Poland, 80-288, Poland

Location

MeSH Terms

Conditions

Nails, Ingrown

Condition Hierarchy (Ancestors)

Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: June 27, 2025
• Study Start: June 27, 2024
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

PL (1)