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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

Information source: Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Onychomycosis

Intervention: Amorolfine (Antifungal) (Drug); RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pierre Fabre Dermo Cosmetique

Official(s) and/or principal investigator(s):
Carle PAUL, Professor, Principal Investigator, Affiliation: Hopital Purpan

Overall contact:
Jean-Jacques VOISARD, MD, Phone: +33 5 63 58 88 00, Email: jean.jacques.voisard@pierre-fabre.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Jean-Jacques VOISARD, MD, Phone: +33 5 63 58 88 00, Email: jean.jacques.voisard@pierre-fabre.com

Cabinet Médical, Argenteuil 95100, France; Recruiting
Yves LE CORRE, MD, Principal Investigator

Cabinet Médical, Brest 29200, France; Recruiting
Monique CHASSAIN LE LAY, MD, Principal Investigator

Cabinet Medical, Cholet 49300, France; Recruiting
Jean-Michel DEBARRE, MD, Principal Investigator

Cabinet Médical, Martigues 13500, France; Recruiting
Mireille RUER-MULLARD, MD, Principal Investigator

Cabinet Médical, Nice 06000, France; Recruiting
Gilles ROSTAIN, MD, Principal Investigator

Cabinet Médical, Toulouse 31000, France; Recruiting
Didier COUSTOU, MD, Principal Investigator

Hopital Purpan, Toulouse, France; Not yet recruiting
Carle PAUL, Professor, Principal Investigator

Additional Information

Starting date: August 2009
Last updated: November 16, 2009

Page last updated: August 23, 2015

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