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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 (ONICO)

Primary Purpose

Onychomycosis

Status

Unknown status

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Amorolfine (Antifungal)

RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)

About this trial

This is an interventional treatment trial for Onychomycosis focused on measuring Dermatomycoses, Infection, Mycoses, Nail diseases, Ski diseases, Skin diseases/infectious

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Cabinet MédicalRecruiting
Cabinet MédicalRecruiting
Cabinet MedicalRecruiting
Cabinet MédicalRecruiting
Cabinet MédicalRecruiting
Cabinet MédicalRecruiting
Hopital Purpan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Amorolfine 5%

RV4104A-cylcopiroxolamine-ciclopirox

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

Averse Events Reporting

Full Information

NCT ID

NCT01014637

First Posted

November 16, 2009

Last Updated

November 16, 2009

Sponsor

Pierre Fabre Dermo Cosmetique

Collaborators

Quanta Medical

1. Study Identification

Unique Protocol Identification Number

NCT01014637

Brief Title

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

Acronym

ONICO

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

August 2009 (undefined)

Primary Completion Date

September 2011 (Anticipated)

Study Completion Date

September 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Pierre Fabre Dermo Cosmetique

Collaborators

Quanta Medical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 involvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Onychomycosis

Keywords

Dermatomycoses, Infection, Mycoses, Nail diseases, Ski diseases, Skin diseases/infectious

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Amorolfine 5%

Arm Type

Active Comparator

Arm Title

RV4104A-cylcopiroxolamine-ciclopirox

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Amorolfine (Antifungal)

Other Intervention Name(s)

Loceryl

Intervention Description

Treatment with Amorolfine for 36 weeks

Intervention Type

Drug

Intervention Name(s)

RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)

Other Intervention Name(s)

RV4104A ointment, Mycoster 1%, Mycoster 8%

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

Day 336

Secondary Outcome Measure Information:

Title

Time Frame

Day 21, Day 77, Day 156, Day 262

Title

Time Frame

Day 336

Title

Time Frame

Day 77, Day 168, Day 252

Title

Averse Events Reporting

Time Frame

Throughout the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean-Jacques VOISARD, MD

Phone

+33 5 63 58 88 00

jean.jacques.voisard@pierre-fabre.com

First Name & Middle Initial & Last Name or Official Title & Degree

Héla COUBETERGUES

Phone

+ 33 5 61 73 73 38

hela.coubetergues@pierre-fabre.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carle PAUL, Professor

Organizational Affiliation

Hopital Purpan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cabinet Médical

City

Argenteuil

ZIP/Postal Code

95100

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yves LE CORRE, MD

Facility Name

Cabinet Médical

City

Brest

ZIP/Postal Code

29200

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Monique CHASSAIN LE LAY, MD

Facility Name

Cabinet Medical

City

Cholet

ZIP/Postal Code

49300

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Michel DEBARRE, MD

Facility Name

Cabinet Médical

City

Martigues

ZIP/Postal Code

13500

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mireille RUER-MULLARD, MD

Facility Name

Cabinet Médical

City

Nice

ZIP/Postal Code

06000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gilles ROSTAIN, MD

Facility Name

Cabinet Médical

City

Toulouse

ZIP/Postal Code

31000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Didier COUSTOU, MD

Facility Name

Hopital Purpan

City

Toulouse

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carle PAUL, Professor

12. IPD Sharing Statement

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