OnychomycosisPhase 4ONICONCT01014637
Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer in Dermatophytic Onychomycosis
A Phase 4 study testing Amorolfine (Antifungal) and RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal) in people with Onychomycosis, run by Pierre Fabre Dermo Cosmetique at 7 sites in France.
Trial summary
The purpose of the study is to evaluate and compare the efficacy of the sequential association RV4104A ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Onychomycosis
- What is being tested?
- Amorolfine (Antifungal) and RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 7 sitesFrance
- Study dates
- Aug 2009to Sep 2011
- 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
- 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) without matrix involvement
- Target nail plate showing between 25% and 60% of clinically infected area
- Patient must have at least 2 mm of unaffected proximal target nail area
- Target nail infection due exclusively to a dermatophyte (from positive fungal culture as reported by the central mycological laboratory)
- Female patient of childbearing potential must use an efficient contraceptive method for at least 2 months prior to screening visit
- Female patient of childbearing potential must have a negative urinary pregnancy test at the screening visit
Who cannot join
- Patient with more than 3 affected nails
- Patient with onychomycosis with matrix involvement
- 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 any topical antifungal therapy applied to the toenails within 3 months prior to screening visit
- Patient with known hypersensitivity to investigational products' ingredient(s)
- Patient who is currently participating or who has participated in another clinical study within 4 weeks prior to screening visit
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Cabinet Médical
Argenteuil, 95100
Yves LE CORRE, MD
- Recruiting
Cabinet Médical
Brest, 29200
Monique CHASSAIN LE LAY, MD
- Recruiting
Cabinet Medical
Cholet, 49300
Jean-Michel DEBARRE, MD
- Recruiting
Cabinet Médical
Martigues, 13500
Mireille RUER-MULLARD, MD
- Recruiting
Cabinet Médical
Nice, 06000
Gilles ROSTAIN, MD
- Recruiting
Cabinet Médical
Toulouse, 31000
Didier COUSTOU, MD
- Not yet recruiting
Hopital Purpan
Toulouse
Carle PAUL, Professor
About this study
Official title: A Multicentre, Randomized, Controlled Study of the Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer Alone for the Treatment of Dermatophytic Onychomycosis (Toenail) Without Matrix Involvement
The purpose of the study is to evaluate and compare the efficacy of the sequential association RV4104A ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement.
- Conditions
- Onychomycosis
- Being tested
- Amorolfine (Antifungal), RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)
- Keywords
- Dermatomycoses, Infection, Mycoses, Nail diseases, Ski diseases, Skin diseases/infectious
- Medical subject headings
- Onychomycosis, Dermatomycoses, Infections, Mycoses, Nail Diseases, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amorolfine (Antifungal)Drug
Also called Loceryl
Treatment with Amorolfine for 36 weeks
RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)Drug
Also called RV4104A ointment, Mycoster 1%, Mycoster 8%
Initial treatment with RV4104A ointment for 3 weeks, followed by treatment with ciclopiroxolamine 1% cream for 8 weeks and by cyclopirox 8% film-forming solution for 25 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Amorolfine 5% | Active comparator | Not described Receives: Drug: Amorolfine (Antifungal) |
| RV4104A-cylcopiroxolamine-ciclopirox | Experimental | Not described Receives: Drug: RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate and compare the efficacy of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in dermatophytic onychomycosis (toenail) without matrix involvement
Measured: Day 336
Secondary outcomes (4)
To evaluate and compare the local tolerability of the sequential association RV4104A-ciclopiroxolamine-ciclopirox versus amorolfine 5% alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement
Measured: Day 21, Day 77, Day 156, Day 262
To evaluate and compare the cost-effectiveness of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution vs amorolfine 5% alone in the treatment of dermatophytic onychomycosis without matrix involvement
Measured: Day 336
To evaluate and compare the clinical cure of the sequential association RV4104A ointment-ciclopiroxolamine-ciclopirox 8 versus amorolfine alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement
Measured: Day 77, Day 168, Day 252
Averse Events 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 posted17 Nov 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quanta Medical
- Investigators
- Carle PAUL, Professor, Principal investigator, Hopital Purpan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014637
- Sponsor's protocol ID
- RV4104A 2008 548
- Acronym
- ONICO
- Status last verified
- Nov 2009
- First submitted
- 16 Nov 2009
- Last updated
- 17 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Controlled Study of the Efficacy, Safety and Cost-effectiveness of a Sequential Therapy With RV4104A Ointment, Ciclopiroxolamine Cream and Ciclopirox Film-forming Solution Compared With Amorolfine Nail Lacquer Alone for the Treatment of Dermatophytic Onychomycosis (Toenail) Without Matrix Involvement
- ClinicalTrials.gov ID
- NCT01014637
- Acronym / sponsor ID
- ONICO / RV4104A 2008 548
- Conditions
- Onychomycosis
- Keywords
- Dermatomycoses, Infection, Mycoses, Nail diseases, Ski diseases, Skin diseases/infectious
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Collaborators
- Quanta Medical
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 17 Nov 2009 (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 and compare the efficacy of the sequential association RV4104A ointment followed by ciclopiroxolamine 1% cream and ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in the treatment of patients with dermatophytic onychomycosis (toenail) without matrix involvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amorolfine 5% | Active comparator | Drug: Amorolfine (Antifungal) |
| RV4104A-cylcopiroxolamine-ciclopirox | Experimental | Drug: RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of distal-lateral or lateral subungual onychomycosis of one great toenail (the target nail) without matrix involvement
- Target nail plate showing between 25% and 60% of clinically infected area
- Patient must have at least 2 mm of unaffected proximal target nail area
- Target nail infection due exclusively to a dermatophyte (from positive fungal culture as reported by the central mycological laboratory)
- Female patient of childbearing potential must use an efficient contraceptive method for at least 2 months prior to screening visit
Key exclusion criteria (7 listed)
- Patient with more than 3 affected nails
- Patient with onychomycosis with matrix involvement
- 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 any topical antifungal therapy applied to the toenails within 3 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 |
|---|---|---|
| Amorolfine (Antifungal)Also: LocerylTreatment with Amorolfine for 36 weeks | Drug | Amorolfine 5% |
| RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)Also: RV4104A ointment, Mycoster 1%, Mycoster 8%Initial treatment with RV4104A ointment for 3 weeks, followed by treatment with ciclopiroxolamine 1% cream for 8 weeks and by cyclopirox 8% film-forming solution for 25 weeks. | Drug | RV4104A-cylcopiroxolamine-ciclopirox |
Primary outcome
To evaluate and compare the efficacy of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in dermatophytic onychomycosis (toenail) without matrix involvement
Time frame: Day 336
4 secondary outcomes
To evaluate and compare the local tolerability of the sequential association RV4104A-ciclopiroxolamine-ciclopirox versus amorolfine 5% alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement
Time frame: Day 21, Day 77, Day 156, Day 262
To evaluate and compare the cost-effectiveness of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution vs amorolfine 5% alone in the treatment of dermatophytic onychomycosis without matrix involvement
Time frame: Day 336
To evaluate and compare the clinical cure of the sequential association RV4104A ointment-ciclopiroxolamine-ciclopirox 8 versus amorolfine alone in the treatment dermatophytic onychomycosis (toenail) without matrix involvement
Time frame: Day 77, Day 168, Day 252
Averse Events 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 17 Nov 2009.
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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
Hopital Purpan
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amorolfine (Antifungal) and RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal) in people with Onychomycosis, run by Pierre Fabre Dermo Cosmetique at 7 sites 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 6 inclusion and 7 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 17 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Jacques VOISARD, MD (+33 5 63 58 88 00, jean.jacques.voisard@pierre-fabre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate and compare the efficacy of the sequential association RV4104A ointment-ciclopiroxolamine 1% cream-ciclopirox 8% film-forming solution versus amorolfine 5% nail lacquer alone in dermatophytic onychomycosis (toenail) without matrix involvement (time frame: Day 336). 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 Nov 2009.