OnychomycosisPhase 4NCT02464826
A Pilot Study - Safety and Efficacy of Nailprotex® for Onychomycosis Treatment
A Phase 4 study testing Nailprotex in people with Onychomycosis and Chronic Paronychia, run by Mahidol University at 1 site in Thailand.
Trial summary
This study was designed to demonstrate the efficacy of this product in non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Onychomycosis, Chronic Paronychia
- What is being tested?
- Nailprotex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2015to Jun 2016
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants was 18 years old or above.
- Participants were diagnosed Scytalidium dimidiatum onychomycosis or chronic paronychia by dermatologists based on clinical presentation and mycological identification.
- Participants accept the aim of this project and sign the consent form by themselves.
Who cannot join
- Participants have other nail disorders before participate the research.
- Participants have the history of immunocompromised host.
- Participants were diagnosed onychomycosis more than 3 nails or matrix involvement.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Dermatology Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
This study was designed to demonstrate the efficacy of this product in non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.
Read the detailed description
Onychomycosis is the common superficial fungal skin infection in general population. According to the previous study, the prevalence of tinea pedis and onychomycosis in general Thai population were 3.8% and 1.7% respectively. However, this problem has been neglected for treatment due to asymptomatic clinical manifestations and low effects in quality of life.
In Thailand, the previous studies reported that the aetiological pathogens of this disorder were non-dermatophyte mold (51.6%), dermatophyte (36.3%) and yeast (6%). Additionally, Scytalidium dimidiatum was the majority causative agents in non-dermatophyte mold.
Systemic therapy such as azoles group and terbinafine is recommended for the standard management of tinea capitis. In contrast, a prolonged course may be induce serious side effects. So that topical therapy is the alternative treatment in older patients who are limited in drug usage. Especially, non-dermatophyte onychomycosis is the recalcitrant condition. Moreover, none of the standard regimen is recommended.
Nailprotex® is the novel topical treatment in onychomycosis and chronic paronychia. The active ingredient is phenol which is extracted from Olea European leaf. It is able to inhibit the fungal growth. Additionally, this product has been applied for nail care in many European countries over 10 years. The serious side effects have never been reported. Therefore, this study was designed to demonstrate the efficacy of this product in non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.
- Conditions
- Onychomycosis, Chronic Paronychia
- Being tested
- Nailprotex
- Keywords
- Onychomycosis, Chronic paronychia, Treatment
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NailprotexDrug
Nailprotex apply to the abnormal nail twice daily
| Study group | Role | What they receive |
|---|---|---|
| Edit arms | Experimental | Nailprotex apply to the abnormal nail twice daily Receives: Drug: Nailprotex |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score from baseline and 6 months-after using Nailprotex®
Patients who were treated by Nailprotex® in this study were evaluated the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score at baseline and after using Nailprotex® 6 months. Then the change in SCIO score was analyzed in percentage and compare mean.
Measured: 6 months
Secondary outcomes (2)
The side effects of Nailprotex®
The side effects of Nailprotex® was observed in patients from date of first application or first side effects documented progression until the date of end of study, assessed up to 6 months.
Measured: 6 months
Mycological cure rate which mean KOH and fungal culture result are both nagative after using Nailprotex® at 6 month after treated with Nailprotex®
Patients who were treated by Nailprotex® in this study were evaluated the results of laboratory investigation (KOH examination and fungal culture) at baseline and after using Nailprotex® 6 months. Then mycological cure rate was analyzed in percentage.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charussri - Leeyaphan, MD., Principal investigator, Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464826
- Sponsor's protocol ID
- Efficacynailprotex
- Status last verified
- Jun 2016
- First submitted
- 30 Apr 2015
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study - Safety and Efficacy of Nailprotex® for Onychomycosis Treatment
- ClinicalTrials.gov ID
- NCT02464826
- Acronym / sponsor ID
- Efficacynailprotex
- Conditions
- Onychomycosis, Chronic Paronychia
- Keywords
- Onychomycosis, Chronic paronychia, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Jun 2015 (estimated)
- 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 was designed to demonstrate the efficacy of this product in non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.
Detailed description
Onychomycosis is the common superficial fungal skin infection in general population. According to the previous study, the prevalence of tinea pedis and onychomycosis in general Thai population were 3.8% and 1.7% respectively. However, this problem has been neglected for treatment due to asymptomatic clinical manifestations and low effects in quality of life.
In Thailand, the previous studies reported that the aetiological pathogens of this disorder were non-dermatophyte mold (51.6%), dermatophyte (36.3%) and yeast (6%). Additionally, Scytalidium dimidiatum was the majority causative agents in non-dermatophyte mold.
Systemic therapy such as azoles group and terbinafine is recommended for the standard management of tinea capitis. In contrast, a prolonged course may be induce serious side effects. So that topical therapy is the alternative treatment in older patients who are limited in drug usage. Especially, non-dermatophyte onychomycosis is the recalcitrant condition. Moreover, none of the standard regimen is recommended.
Nailprotex® is the novel topical treatment in onychomycosis and chronic paronychia. The active ingredient is phenol which is extracted from Olea European leaf. It is able to inhibit the fungal growth. Additionally, this product has been applied for nail care in many European countries over 10 years. The serious side effects have never been reported. Therefore, this study was designed to demonstrate the efficacy of this product in non-dermatophyte (Scytalidium dimidiatum) onychomycosis and chronic paronychia treatment in Thai patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Edit arms | Experimental | Drug: NailprotexNailprotex apply to the abnormal nail twice daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female participants was 18 years old or above.
- Participants were diagnosed Scytalidium dimidiatum onychomycosis or chronic paronychia by dermatologists based on clinical presentation and mycological identification.
- Participants accept the aim of this project and sign the consent form by themselves.
Key exclusion criteria (3 listed)
- Participants have other nail disorders before participate the research.
- Participants have the history of immunocompromised host.
- Participants were diagnosed onychomycosis more than 3 nails or matrix involvement.
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 |
|---|---|---|
| NailprotexNailprotex apply to the abnormal nail twice daily | Drug | Edit arms |
Primary outcome
The change in the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score from baseline and 6 months-after using Nailprotex®
Time frame: 6 months
Patients who were treated by Nailprotex® in this study were evaluated the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score at baseline and after using Nailprotex® 6 months. Then the change in SCIO score was analyzed in percentage and compare mean.
2 secondary outcomes
The side effects of Nailprotex®
Time frame: 6 months
Mycological cure rate which mean KOH and fungal culture result are both nagative after using Nailprotex® at 6 month after treated with Nailprotex®
Time frame: 6 months
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 17 Jun 2016.
Related trials for Onychomycosis
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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.
Charussri - Leeyaphan, MD. principal investigator
Department of Dermatology Faculty of Medicine, Siriraj Hospital Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nailprotex in people with Onychomycosis and Chronic Paronychia, run by Mahidol University at 1 site in Thailand.
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 3 inclusion and 3 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 17 Jun 2016. 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 Thailand. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The change in the severity of onychomycosis by using SCIO (Scoring Clinical Index for Onychomycosis) score from baseline and 6 months-after using Nailprotex® (time frame: 6 months). 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 17 Jun 2016.