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Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis

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ClinicalTrials.gov Identifier: NCT04961684
Recruitment Status : Completed
First Posted : July 14, 2021
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Oystershell NV

Brief Summary:
The efficacy and safety of Solver Pen (prototype number X92001704) is evaluated in this randomized, open label, controlled, investigator-blinded, comparative clinical trial in 76 patients. Subjects are treated with either the test medical device (Solver Pen) or the comparator (Loceryl, 5% amorolfine), respectively, for a period of 90 days. The primary objective of the investigation is the increase of percentage of healthy surface on the great toenail at study end versus baseline, as evaluated by a blinded investigator. Patients are followed up for a period of 90 days, with visits at D0 (baseline), D30, D60 and D90, respectively.

Condition or disease Intervention/treatment Phase
Onychomycosis of Toenail Device: Solver Pen Drug: Loceryl 5% Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
Actual Study Start Date : February 10, 2020
Actual Primary Completion Date : September 22, 2020
Actual Study Completion Date : September 22, 2020

Arm Intervention/treatment
Experimental: Solver Pen Device: Solver Pen
One application per day for 3 months

Active Comparator: Loceryl 5% Drug: Loceryl 5%
One application per week for 3 months




Primary Outcome Measures :
  1. Percentage of healthy surface (performance) [ Time Frame: 90 days ]
    Variation of the percentage of healthy surface after 90 days of treatment with the test medical device or reference versus baseline value. Evaluation is done in blind by digital analysis of photographs of the great, infected toenail.


Secondary Outcome Measures :
  1. Percentage of healthy surface (performance) [ Time Frame: 30 and 60 days ]
    Variation of the percentage of healthy surface after 30 and 60 days of treatment with the test medical device or reference versus baseline. Blinded evaluation is performed by digital analysis of photographs of the great, infected toenail.

  2. Microbiological efficacy: KOH staining (performance) [ Time Frame: 90 days ]
    Evaluation of microbiological efficacy of both treatments by KOH staining on D90 versus baseline.

  3. Microbiological efficacy: fungal culture (performance) [ Time Frame: 90 days ]
    Evaluation of microbiological efficacy of both treatments by fungal culture on D90 versus baseline.

  4. Clinical efficacy: onychomycosis evolution (performance) [ Time Frame: 30, 60 and 90 days ]
    Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of onychomycosis evolution on a 4-point scale (failure to success)

  5. Clinical efficacy: onycholysis (performance) [ Time Frame: 30, 60 and 90 days ]
    Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of onycholysis on a 5-point scale (none to severe)

  6. Clinical efficacy: nail distrophy (performance) [ Time Frame: 30, 60 and 90 days ]
    Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of nail distrophy on a 5-point scale (none to severe)

  7. Clinical efficacy: nail discoloration (performance) [ Time Frame: 30, 60 and 90 days ]
    Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of nail discoloration on a 5-point scale (none to severe)

  8. Clinical efficacy: nail thickening (performance) [ Time Frame: 30, 60 and 90 days ]
    Blinded assessment of clinical efficacy of both treatments on D0 (baseline), D30, D60 and D90 by evaluation of nail thickening on a 5-point scale (none to severe)

  9. Impact on quality of life (performance) [ Time Frame: 60 and 90 days ]
    Evaluation of the impact on the quality of life (QoL) of the patients using a validated questionnaire (NailQoL: Nail Questionnaire Of Life from 0=no impact on life quality to 100=maximum impact on life quality) before (baseline) and 60 and 90 days of treatment with the test medical device or reference, respectively.

  10. Subjective evaluation questionnaire for the patient (performance) [ Time Frame: 14, 30, 60 and 90 days of treatment ]
    Evaluation of efficacy, tolerance, and acceptability cosmetic aspect, usability…) of the investigational device by the patients using a subjective evaluation questionnaire (answers to questions with 5 modalities from "strongly disagree" to "strongly agree"), performed at each visit and at D14 (via phone).

  11. Assessment of local tolerance by the investigator (safety and tolerability) [ Time Frame: 30, 60 and 90 days ]
    Evaluation of local tolerance of the test medical device at each visit. Assessment is performed by the investigator via clinical evaluation and subject interrogation on a scale from 0 (bad tolerance) to 3 (very good tolerance)

  12. Incidence of Adverse events (safety and tolerability) [ Time Frame: 30, 60 and 90 days ]
    Collection of Adverse events and adverse device effects throughout the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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. Age: more than 18 years.
  5. Subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement <2/3 of the tablet).
  6. Patient with positive KOH staining.
  7. Patient having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion.
  8. Women of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after study end.

Exclusion Criteria:

  1. Pregnant or nursing woman or planning a pregnancy during the investigation;
  2. Patient considered by the Investigator likely to be non-compliant with the protocol.
  3. Patient enrolled in another clinical trial during the test period.
  4. Subject having a known allergy to one of the constituents of the tested products.
  5. Patient with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk;
  6. Patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology…
  7. Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04961684


Locations
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Tunisia
Pr Doss office
Tunis, Tunisia
Sponsors and Collaborators
Oystershell NV
Investigators
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Principal Investigator: Nejib Doss, MD Eurofins Dermscan Tunisia
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Responsible Party: Oystershell NV
ClinicalTrials.gov Identifier: NCT04961684    
Other Study ID Numbers: 19E2407
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Amorolfine
Antifungal Agents
Anti-Infective Agents