OnychomycosisNCT00808366
Efficacy and Safety of RV4104A Ointment in Onychomycosis
A study testing Keratolytic/Antifungal in people with Onychomycosis, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
The purpose of the study is to evaluate the efficacy of RV4104A ointment versus bifonazole-urea ointment for the complete removal of the clinically infected nail plate area in patients with toenail onychomycosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Keratolytic/Antifungal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Oct 2009
- 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
- Clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail)
- Target nail plate showing ≥ 12.5% of clinically infected area
- Patient must have at least 2 mm of the proximal end of the target nail free of infection
- Target nail infection due exclusively to a dermatophyte (from both positive direct microscopy examination and positive fungal culture as reported by the central mycological laboratory)
Who cannot join
- Patient with more than 2 affected toenails
- Patient with psoriasis, lichen planus or other abnormalities that could result in clinically abnormal toenail(s)
- Patient with moccasin-type tinea pedis
- Patient who has received systemic antifungal therapy or topical antifungal nail lacquer within 3 months or any other topical antifungal therapy applied to the feet or toenails within 2 months prior to screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Parallel-Group, Multicentre, Open-Labelled, Active-Controlled Study to Assess the Efficacy, Safety and Tolerability of RV4104A Ointment Versus Bifonazole-Urea Ointment for the Complete Removal of the Clinically Infected Nail Plate Area in Patients With Toenail Onychomycosis
The purpose of the study is to evaluate the efficacy of RV4104A ointment versus bifonazole-urea ointment for the complete removal of the clinically infected nail plate area in patients with toenail onychomycosis.
- Conditions
- Onychomycosis
- Being tested
- Keratolytic/Antifungal
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keratolytic/AntifungalDrug
Intial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
Keratolytic/AntifungalDrug
Initial treatment with bifonazole-urea ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| RV4104A ointment | Experimental | Not described Receives: Drug: Keratolytic/Antifungal |
| bifonazole-urea ointment | Active comparator | Not described Receives: Drug: Keratolytic/Antifungal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by a blinded imaging expert's panel on the basis of standardized photographs
Measured: D21
Secondary outcomes (7)
Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by the investigator on the basis of clinical evaluation
Measured: D21
Patient self-assessment
Measured: D21, D77, D105
Clinical cure
Measured: D77, D105
Mycological cure
Measured: D105
Complete cure of onychomycosis
Measured: D105
Local tolerability
Measured: D7, D21
Adverse Event reporting
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startOct 2008
- Primary completionJun 2009 (estimated)
- Study completionOct 2009 (estimated)
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.
- 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
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carle PAUL, Professor, Principal investigator, Hôpital Purpan, Toulouse - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808366
- Sponsor's protocol ID
- RV4104A2007593
- Status last verified
- Dec 2008
- First submitted
- 12 Dec 2008
- Last updated
- 15 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Multicentre, Open-Labelled, Active-Controlled Study to Assess the Efficacy, Safety and Tolerability of RV4104A Ointment Versus Bifonazole-Urea Ointment for the Complete Removal of the Clinically Infected Nail Plate Area in Patients With Toenail Onychomycosis
- ClinicalTrials.gov ID
- NCT00808366
- Acronym / sponsor ID
- RV4104A2007593
- Conditions
- Onychomycosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 15 Dec 2008 (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.
The purpose of the study is to evaluate the efficacy of RV4104A ointment versus bifonazole-urea ointment for the complete removal of the clinically infected nail plate area in patients with toenail onychomycosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RV4104A ointment | Experimental | Drug: Keratolytic/Antifungal |
| bifonazole-urea ointment | Active comparator | Drug: Keratolytic/Antifungal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail)
- Target nail plate showing ≥ 12.5% of clinically infected area
- Patient must have at least 2 mm of the proximal end of the target nail free of infection
- Target nail infection due exclusively to a dermatophyte (from both positive direct microscopy examination and positive fungal culture as reported by the central mycological laboratory)
Key exclusion criteria (4 listed)
- Patient with more than 2 affected toenails
- Patient with psoriasis, lichen planus or other abnormalities that could result in clinically abnormal toenail(s)
- Patient with moccasin-type tinea pedis
- Patient who has received systemic antifungal therapy or topical antifungal nail lacquer within 3 months or any other topical antifungal therapy applied to the feet or toenails within 2 months prior to screening visit
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 |
|---|---|---|
| Keratolytic/AntifungalIntial treatment with RV4104A ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks. | Drug | RV4104A ointment |
| Keratolytic/AntifungalInitial treatment with bifonazole-urea ointment for 3 weeks. Subsequent topical antifungal treatment with bifonazole cream for 8 weeks. | Drug | bifonazole-urea ointment |
Primary outcome
Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by a blinded imaging expert's panel on the basis of standardized photographs
Time frame: D21
7 secondary outcomes
Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by the investigator on the basis of clinical evaluation
Time frame: D21
Patient self-assessment
Time frame: D21, D77, D105
Clinical cure
Time frame: D77, D105
Mycological cure
Time frame: D105
Complete cure of onychomycosis
Time frame: D105
Local tolerability
Time frame: D7, D21
Adverse Event reporting
Time frame: Throughout the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2008.
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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.
Carle PAUL, Professor principal investigator
Hôpital Purpan, Toulouse - FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keratolytic/Antifungal in people with Onychomycosis, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 15 Dec 2008. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marine Maigret, PhD (+33.5.62.48.85.92, marine.maigret@pierre-fabre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete removal of the clinically infected target nail plate area after treating for 3 weeks assessed by a blinded imaging expert's panel on the basis of standardized photographs (time frame: D21). 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 15 Dec 2008.