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Ingrown ToenailsNCT07041047

Evaluation of Apaisant Serum - Ingrown Nails for Ingrown Toenails

A study testing APAISANT SERUM - INGROWN NAILS in people with Ingrown Toenails and Ingrown Nail Inflammation, run by Swiss Footcare Laboratories - Poderm Professional at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 years and older
Conditions the study is for
Ingrown Toenails, Ingrown Nail Inflammation
What is being tested?
APAISANT SERUM - INGROWN NAILS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 sitePoland
Study dates
27 Jun 2024to 20 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Eurofins Dermscan Poland

    Gdansk, Poland, 80-288

Other trials in Poland

About this study

Official title: 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.

Read the 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.

Being tested
APAISANT SERUM - INGROWN NAILS
Keywords
Ingrown nails, Ingrown toenails treatment, Pain relief, Topical treatment, Medical device, Nail inflammation, Clinical study on ingrown nails
Medical subject headings
Nails, Ingrown

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APAISANT SERUM - INGROWN NAILSDevice

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

Study groups in NCT07041047
Study groupRoleWhat they receive
Evaluation of Apaisant Serum - Ingrown nails for Ingrown ToenailsExperimentalSubjects 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.
Receives: Device: APAISANT SERUM - INGROWN NAILS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 7 (D7) compared to baseline (D0)

Secondary outcomes (20)
  1. Change in discomfort severity of the ingrown toenail

    Discomfort severity will be measured using the Numerical Rating Scale (NRS), ranging from 0 (no discomfort) to 10 (worst possible discomfort). Higher scores indicate a worse outcome.

    Measured: Day 7 (D7) compared to baseline (D0)

  2. Improvement in ingrown nail symptom - redness

    Redness will be assessed using a 0-10 point Numerical Rating Scale (NRS), where 0 indicates no redness and 10 indicates the most severe redness. Higher scores indicate a worse outcome.

    Measured: Day 7 (D7) compared to baseline (D0)

  3. Improvement in ingrown nail symptom - edema

    Edemawill be assessed using a 0-10 point Numerical Rating Scale (NRS), where 0 indicates no edema and 10 indicates the most severe edema. Higher scores indicate a worse outcome.

    Measured: Day 7 (D7) compared to baseline (D0)

  4. Improvement in ingrown nail symptoms - inflammation

    Inflammation will be assessed using a 0-10 point Numerical Rating Scale (NRS), where 0 indicates no inflammation and 10 indicates the most severe inflammation. Higher scores indicate a worse outcome.

    Measured: Day 7 (D7) compared to baseline (D0)

  5. Improvement in ingrown nail symptoms - pain touch

    Pain on touch will be assessed using a 0-10 point Numerical Rating Scale (NRS), where 0 indicates no pain on touch and 10 indicates the most severe pain on touch. Higher scores indicate a worse outcome.

    Measured: Day 7 (D7) compared to baseline (D0)

  6. Improvement in ingrown nail symptoms - irritation

    Irritation will be assessed using a 0-10 point Numerical Rating Scale (NRS), where 0 indicates no irritation and 10 indicates the most severe irritation. Higher scores indicate a worse outcome.

    Measured: Day 7 (D7) compared to baseline (D0)

  7. Improvement in ingrown nail symptoms - overall appearance of the nails

    The overall appearance of the nails will be assessed using a 0-10 Numerical Rating Scale (NRS), where 0 indicates an unhealthy-looking nail and 10 indicates a completely healthy-looking nail. Higher scores indicate a better outcome.

    Measured: Day 7 (D7) compared to baseline (D0)

  8. Improvement in ingrown nail symptoms - gloss appearance of the nail

    Gloss appearance of the nail will be assessed using a 0-10 Numerical Rating Scale (NRS), where 0 indicates a dull nail and 10 indicates a very glossy nail. Higher scores indicate a better outcome.

    Measured: Day 7 (D7) compared to baseline (D0)

  9. Improvement in ingrown nail symptoms - nail smoothness

    Nail smoothness will be assessed using a 0-10 Numerical Rating Scale (NRS), where 0 indicates a rough nail and 10 indicates a very smooth nail. Higher scores indicate a better outcome.

    Measured: Day 7 (D7) compared to baseline (D0)

  10. Improvement in ingrown nail symptoms - the softness of the nail and its contour

    The softness of the nail and its contour will be assessed using a 0-10 Numerical Rating Scale (NRS), where 0 indicates a tough, callous nail and contour, and 10 indicates a soft nail and contour. Higher scores indicate a better outcome.

    Measured: Day 7 (D7) compared to baseline (D0)

  11. Improvement in ingrown nail symptoms - nail nourishment

    Nail nourishment will be assessed using a 0-10 Numerical Rating Scale (NRS), where 0 indicates a dry, weak, unnourished nail and 10 indicates a very nourished nail. Higher scores indicate a better outcome.

    Measured: Day 7 (D7) compared to baseline (D0)

  12. Change in pain over time

    Pain levels will be recorded daily by participants using the Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate a worse outcome.

    Measured: From Day 1 (D1) to Day 7 (D7) compared to baseline (D0)

  13. Change in discomfort over time

    Discomfort levels will be recorded daily by participants using the Numerical Rating Scale (NRS), ranging from 0 (no discomfort) to 10 (worst possible discomfort). Higher scores indicate a worse outcome.

    Measured: From Day 1 (D1) to Day 7 (D7) compared to baseline (D0)

  14. Investigator Global Assessment (IGA) Score

    The investigator will evaluate overall improvement using a standardized clinical assessment scale ranging from -1 (worse) to 3 (very good improvement). Higher scores indicate a better outcome.

    Measured: Day 7 (D7)

  15. Patient Global Assessment (PGA) Score

    Participants will provide their own global assessment of improvement using a standardized scale ranging from -1 (worse) to 3 (very good improvement). Higher scores indicate a better outcome.

    Measured: Day 7 (D7)

  16. Subjective evaluation of general appreciation of the product

    Participants will rate their general appreciation of the product and its properties on a scale from 1 (very unpleasant) to 5 (very pleasant).

    Measured: Day 7 (D7)

  17. Subjective evaluation of efficacy

    Participants will indicate their level of agreement with statements regarding product effectiveness on a scale from 1 (strongly disagree) to 5 (strongly agree).

    Measured: Day 7 (D7)

  18. Subjective evaluation of future use of the product

    Participants will answer Yes or No to questions about their intention to use the product in the future.

    Measured: Day 7 (D7)

  19. Tolerance and safety assessment

    Any adverse events (AEs) will be collected and analyzed to evaluate the safety profile of the investigational device throughout the study.

    Measured: Throughout the study (D0-D7)

  20. Illustrative macrophotographs

    Standardized images will be taken to document the visual improvement of the ingrown toenail condition throughout the study.

    Measured: Day 0 (D0) and Day 7 (D7)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2025
  2. Study start27 Jun 2024
  3. Primary completion20 Aug 2024
  4. Study completion20 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07041047
Sponsor's protocol ID
23E2009
Status last verified
Jun 2025
First submitted
17 Mar 2025
Last updated
27 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Data sharing plans have not yet been finalized. A decision will be made later.

Questions about this trial

What is this clinical trial studying?

A study testing APAISANT SERUM - INGROWN NAILS in people with Ingrown Toenails and Ingrown Nail Inflammation, run by Swiss Footcare Laboratories - Poderm Professional at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain severity of the ingrown toenail (time frame: Day 7 (D7) compared to baseline (D0)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.

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