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| Name | Class |
|---|---|
| Quanta Medical | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amorolfine 5% | Active Comparator |
| |
| RV4104A-cylcopiroxolamine-ciclopirox | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amorolfine (Antifungal) | Drug | Treatment with Amorolfine for 36 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 336 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Jacques VOISARD, MD | Contact | +33 5 63 58 88 00 | jean.jacques.voisard@pierre-fabre.com | |
| Héla COUBETERGUES | Contact | + 33 5 61 73 73 38 | hela.coubetergues@pierre-fabre.com |
| Name | Affiliation | Role |
|---|---|---|
| Carle PAUL, Professor | Hopital Purpan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cabinet Médical | Recruiting | Argenteuil | 95100 | France |
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| RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal) | Drug | 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. |
|
|
| 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 | Day 77, Day 168, Day 252 |
| Averse Events Reporting | Throughout the study |
| Cabinet Médical | Recruiting | Brest | 29200 | France |
|
| Cabinet Medical | Recruiting | Cholet | 49300 | France |
|
| Cabinet Médical | Recruiting | Martigues | 13500 | France |
|
| Cabinet Médical | Recruiting | Nice | 06000 | France |
|
| Cabinet Médical | Recruiting | Toulouse | 31000 | France |
|
| Hopital Purpan | Not yet recruiting | Toulouse | France |
|
| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| D003881 | Dermatomycoses |
| D007239 | Infections |
| D009181 | Mycoses |
| D009260 | Nail Diseases |
| D002481 | Cellulitis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D001423 | Bacterial Infections and Mycoses |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013492 | Suppuration |
| D003240 | Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C038974 | amorolfine |
| D000935 | Antifungal Agents |
| D000077768 | Ciclopirox |
| D007641 | Keratolytic Agents |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011728 | Pyridones |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003879 | Dermatologic Agents |
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