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Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03289871
Recruitment Status : Completed
First Posted : September 21, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Oystershell NV

Brief Summary:
This study evaluates the effect of the medical device "Excilor® Fungal Nail Infection" in the treatment of toenail onychomycosis. Half of the participants will receive the tested product and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.

Condition or disease Intervention/treatment Phase
Onychomycosis Device: Excilor Drug: Loceryl 5% Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Efficacy of a Medical Device in Treatment of Toenail Onychomycosis
Study Start Date : January 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: Excilor
2 applications per day for 6 months
Device: Excilor
Active Comparator: Loceryl 5%
1 application per week for 6 months
Drug: Loceryl 5%



Primary Outcome Measures :
  1. At the end of the study (day 168), evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product. [ Time Frame: After 168 days of treatment ]
    Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.


Secondary Outcome Measures :
  1. At different time points, evolution of the percentage of healthy surface versus baseline, was evaluated by a blinded investigator. Comparison with the comparator product. [ Time Frame: After 14, 28, 56 and 112 days of treatment ]
    Percentage healthy surface was assessed using digital image analysis. Briefly, two macro-photographs (top and front) were made of the great toenail, placed beside a piece of graph paper to allow determination of the exact size of the nail during analysis (contour tracing). Consequently, all pictures were digitalised and recorded on the computer. Image analysis of the top picture was performed with Adobe Photoshop software. For each photograph, a blinded dermatologist traced the healthy surface.

  2. Evaluation of the clinical efficacy assessed by the investigator with structured scales. Comparison with the comparator product. [ Time Frame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168 ]

    Onycholysis, nail dystrophy, nail discoloration and nail thickening were assessed using the following scores:

    0 = none, 1 = very slight, 2 = slight, 3 =moderate, and 4 = severe.


  3. Evaluation of the microbiological efficacy of the product assessed by fungal culture and comparison with the comparator product. [ Time Frame: On baseline (day zero) and day 168 ]
  4. Evaluation of the product tolerance, assessed by the investigator by clinical evaluation and subject interrogatory with a score from 0 (bad tolerance) to 3 (very good tolerance). [ Time Frame: After 14, 28, 56 and 112 days of treatment ]
  5. Evaluation of the quality of life of the subjects thanks to the questionnaire NailQoL . Comparison with the comparator product. [ Time Frame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168 ]
  6. Subjective evaluation by subjects by completing the subjective evaluation questionnaire at each visit. [ Time Frame: On Day 0, Day 14, Day 28, Day 56, Day 112 and Day 168 ]


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:

  • Subject having given her/his informed, written consent,
  • Subject 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.
  • Subject being psychologically able to understand information and to give their/his/her consent.
  • Age: more than 18 years.
  • 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).
  • Subject with positive results of KOH staining.
  • Subject 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.
  • Female subjects 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 the study end.

Exclusion Criteria:

  • Subject considered by the Investigator likely to be non-compliant with the protocol.
  • Patient enrolled in another clinical trial during the test period.
  • Woman being pregnant, nursing or planning a pregnancy during the course of this study.
  • Subject having a known allergy to one of the constituents of the tested products.
  • Patient suffering from serious or progressive diseases (to investigator's discretion), such as diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology….
  • 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): NCT03289871


Locations
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Tunisia
Hospital Habib Thameur
Tunis, Tunisia
Principal instruction military hospital
Tunis, Tunisia
Sponsors and Collaborators
Oystershell NV
Investigators
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Principal Investigator: Nejib Doss, MD Principal Instruction military hospital of Tunis

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Responsible Party: Oystershell NV
ClinicalTrials.gov Identifier: NCT03289871    
Other Study ID Numbers: 14E0752
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: May 2016
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