Onychomycosis of ToenailNCT03382717
Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis
A study testing Excilor Forte and Loceryl 5% in people with Onychomycosis of Toenail, run by Oystershell NV at 2 sites in Tunisia.
Trial summary
This study evaluates the effect of the medical device "Excilor® Forte" 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- Excilor Forte and Loceryl 5%
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesTunisia
- Study dates
- 26 Oct 2016to 26 Aug 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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 study end.
Who cannot join
- 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 uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology…
- Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
Trial locations and contacts
2 sites in 1 country.
Tunisia2 sites
Hospital Habib Thameur
Tunis
Principal instruction military hospital
Tunis
About this study
Official title: Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis.
This study evaluates the effect of the medical device "Excilor® Forte" 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.
Read the detailed description
Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the % of healthy surface (primary end point) of the great toenail was performed to compare the effect of both treatments, and to evaluate improvement versus baseline (day 0), respectively. Additionally, blind assessment of the percentage of healthy surface of the great toenail was performed at all other visits (D30, D60, D120) to evaluate changes from baseline between both treatment groups. For this purpose, digital macrophotographs were analysed by a blinded investigator using Adobe Photoshop software.
- Conditions
- Onychomycosis of Toenail
- Being tested
- Excilor Forte, Loceryl 5%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Excilor ForteDevice
1 application per day during 6 months
Loceryl 5%Drug
1 application per week during 6 months
| Study group | Role | What they receive |
|---|---|---|
| Excilor Forte | Experimental | One application of the MD daily (at same time point), preferably after showering/bathing, during the complete study period. Receives: Device: Excilor Forte |
| Loceryl 5% | Active comparator | One application per week of the positive control Loceryl 5% during the whole study period. Receives: Drug: Loceryl 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail
Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the percentage of healthy surface (primary efficacy endpoint) of the great toenail was performed to evaluate changes from baseline between both treatment groups. Additionally, blind assessment of the percentage of healthy surface of the great toenail will be performed at all other visits (day 30, 60, and 120, respectively) to evaluate changes from baseline between both treatment groups
Measured: After 30, 60, 120 and 180 days of treatment
Secondary outcomes (5)
Evaluation of clinical efficacy by the investigator, assessing the following parameters: onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening, following treatment with test medical device versus reference product.
Onycholysis, nail distrophy, nail discoloration, and nail thickening was evaluated by a blinded investigator, using the following scores: 0 = none, 1 = very slight, 2 = slight, 3 = moderate, and 4 = severe. Onychomycosis evolution was scored as follows: 1 = failure (aggravation, increase total infected area), 2 = status quo, 3 = improvement (decrease of total infected area), 4 = success: disappearance of the total infected area. In order to compare changes in nail dystrophy, discoloration, and nail thickening between baseline and day 180, five categories were reduced to two categories (none to slight versus moderate to severe). The Mc Nemar test for paired data was used to test if there was a change in nail dystrophy, discoloration, and nail thickening between baseline and day 180. A chi-square test test was performed to compare changes between both treatments in onychomycosis evolution.
Note: scores are used and for this reason, no units of measure can be assigned.
Measured: After 30, 60, 120 and 180 days of treatment
Evaluation of microbiological efficacy of the product, using KOH staining and fungal culture on D0 and D180 versus reference product.
Patients with positive KOH staining were included in the study. In addition, a fungal culture was performed to identify the involved species. At day 180, a new KOH staining and fungal culture was performed to evaluate the impact of each treatment on both microbiological parameters.
Measured: At baseline (day 0) and after 180 days of treatment
Evaluation of product tolerance at each visit during the trial, assessed by the investigator by clinical evaluation and subject interrogatory.
The investigator assigned a score from 0 (bad tolerance) to 3 (very good tolerance).
Measured: After 30, 60, 120 and 180 days of treatment
Evaluation of the quality of life of the subjects using a validated questionnaire (NailQoL) before (baseline), after 60 and 180 days of treatment with test product, versus comparator.
A NailQol global score of 0 corresponds with a quality of life never altered by onychomycosis, whereas a score of 100 corresponds to a quality of life that is always affected by onychomycosis.
Measured: After 60 and 180 days of treatment
Subject evaluation using an evaluation questionnaire, performed at each visit.
A questionnaire was included to evaluate product usability and functionality of Excilor Forte. The questionnaire was completed at each evaluation point (day 30, 60, 120, and 180, respectively). General questions were asked regarding the cosmetic effect (e.g. smoothening, brightening effect, conventional packaging..), overall satisfaction (e.g. smell, fits daily routine ...), product application (e.g. ease of application, drying time, stress-resistance, combination with top coat...), purchase intent and tolerance were asked. Subjects needed to score as follows: strongly agree, agree, neutral, disagree, strongly disagree, not concerned. Data were summarized in frequencies.
Measured: After 30, 60, 120 and 180 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start26 Oct 2016
- Primary completion26 Aug 2017
- Study completion26 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Onychomycosis of ToenailStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oystershell NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nejib Doss, MD, Principal investigator, Principal Instruction military hospital of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382717
- Sponsor's protocol ID
- 16E1078
- Status last verified
- Mar 2024
- First submitted
- 11 Dec 2017
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eertmans F, Doss N, Rossel B, Adriaens E. Daily Application of an Aqueous, Acidifying, Peelable Nail Polish versus Weekly Amorolfine for Topical Onychomycosis Treatment: A Prospective, Randomized, Blinded Trial. Dermatol Ther (Heidelb). 2018 Sep;8(3):463-473. doi: 10.1007/s13555-018-0254-1. Epub 2018 Jul 26.
PubMed 30051298
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis.
- ClinicalTrials.gov ID
- NCT03382717
- Acronym / sponsor ID
- 16E1078
- Conditions
- Onychomycosis of Toenail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Oystershell NVIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2016 (actual)
- Primary completion
- 26 Aug 2017 (actual)
- Study completion
- 26 Aug 2017 (actual)
- First posted
- 26 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effect of the medical device "Excilor® Forte" 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.
Detailed description
Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the % of healthy surface (primary end point) of the great toenail was performed to compare the effect of both treatments, and to evaluate improvement versus baseline (day 0), respectively. Additionally, blind assessment of the percentage of healthy surface of the great toenail was performed at all other visits (D30, D60, D120) to evaluate changes from baseline between both treatment groups. For this purpose, digital macrophotographs were analysed by a blinded investigator using Adobe Photoshop software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Excilor Forte | Experimental | Device: Excilor ForteOne application of the MD daily (at same time point), preferably after showering/bathing, during the complete study period. |
| Loceryl 5% | Active comparator | Drug: Loceryl 5%One application per week of the positive control Loceryl 5% during the whole study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject having given her/his informed, written consent.
Key exclusion criteria (6 listed)
- Subject considered by the Investigator likely to be non-compliant with the protocol.
- Patient enrolled in another clinical trial during the test period.
- 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 uncontrolled diabetes, peripheral circulatory disease, HIV, psoriasis, lichen planus, immunosuppressive pathology…
- Subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis…).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Excilor Forte1 application per day during 6 months | Device | Excilor Forte |
| Loceryl 5%1 application per week during 6 months | Drug | Loceryl 5% |
Primary outcome
Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail
Time frame: After 30, 60, 120 and 180 days of treatment
Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the percentage of healthy surface (primary efficacy endpoint) of the great toenail was performed to evaluate changes from baseline between both treatment groups. Additionally, blind assessment of the percentage of healthy surface of the great toenail will be performed at all other visits (day 30, 60, and 120, respectively) to evaluate changes from baseline between both treatment groups
5 secondary outcomes
Evaluation of clinical efficacy by the investigator, assessing the following parameters: onychomycosis evolution, onycholysis, dystrophy, discoloration, and nail thickening, following treatment with test medical device versus reference product.
Time frame: After 30, 60, 120 and 180 days of treatment
Evaluation of microbiological efficacy of the product, using KOH staining and fungal culture on D0 and D180 versus reference product.
Time frame: At baseline (day 0) and after 180 days of treatment
Evaluation of product tolerance at each visit during the trial, assessed by the investigator by clinical evaluation and subject interrogatory.
Time frame: After 30, 60, 120 and 180 days of treatment
Evaluation of the quality of life of the subjects using a validated questionnaire (NailQoL) before (baseline), after 60 and 180 days of treatment with test product, versus comparator.
Time frame: After 60 and 180 days of treatment
Subject evaluation using an evaluation questionnaire, performed at each visit.
Time frame: After 30, 60, 120 and 180 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Derived from this study: PubMed 30051298Eertmans F, Doss N, Rossel B, Adriaens E. Daily Application of an Aqueous, Acidifying, Peelable Nail Polish versus Weekly Amorolfine for Topical Onychomycosis Treatment: A Prospective, Randomized, Blinded Trial. Dermatol Ther (Heidelb). 2018 Sep;8(3):463-473. doi: 10.1007/s13555-018-0254-1. Epub 2018 Jul 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nejib Doss, MD principal investigator
Principal Instruction military hospital of Tunis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Excilor Forte and Loceryl 5% in people with Onychomycosis of Toenail, run by Oystershell NV at 2 sites in Tunisia.
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 8 inclusion and 6 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 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tunisia. 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?
Variation of the percentage of healthy surface after 30, 60, 120, and 180 days between both treatments, and versus baseline. Evaluation is done by digital analysis of photographs of the great, infected toenail (time frame: After 30, 60, 120 and 180 days of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03382717, which also lists 1 linked publication.
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 15 Mar 2024.