Trial record 10 of 20 for:    Open Studies | "Tinea"

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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Pierre Fabre Dermo Cosmetique.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Quanta Medical
Information provided by:
Pierre Fabre Dermo Cosmetique
ClinicalTrials.gov Identifier:
NCT01014637
First received: November 16, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Onychomycosis
Drug: Amorolfine (Antifungal)
Drug: RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Dermo Cosmetique:

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 [ Time Frame: Day 336 ] [ Designated as safety issue: No ]

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 [ Time Frame: Day 21, Day 77, Day 156, Day 262 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Averse Events Reporting [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 260
Study Start Date: August 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Amorolfine 5% Drug: Amorolfine (Antifungal)
Treatment with Amorolfine for 36 weeks
Other Name: Loceryl
Experimental: RV4104A-cylcopiroxolamine-ciclopirox Drug: RV4104A, Ciclopiroxolamine, Cyclopirox (Keratolytic Agents/Antifungal)
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.
Other Names:
  • RV4104A ointment
  • Mycoster 1%
  • Mycoster 8%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014637

Contacts
Contact: Jean-Jacques VOISARD, MD +33 5 63 58 88 00 jean.jacques.voisard@pierre-fabre.com
Contact: Héla COUBETERGUES + 33 5 61 73 73 38 hela.coubetergues@pierre-fabre.com

Locations
France
Cabinet Médical Recruiting
Argenteuil, France, 95100
Principal Investigator: Yves LE CORRE, MD         
Cabinet Médical Recruiting
Brest, France, 29200
Principal Investigator: Monique CHASSAIN LE LAY, MD         
Cabinet Medical Recruiting
Cholet, France, 49300
Principal Investigator: Jean-Michel DEBARRE, MD         
Cabinet Médical Recruiting
Martigues, France, 13500
Principal Investigator: Mireille RUER-MULLARD, MD         
Cabinet Médical Recruiting
Nice, France, 06000
Principal Investigator: Gilles ROSTAIN, MD         
Hopital Purpan Not yet recruiting
Toulouse, France
Principal Investigator: Carle PAUL, Professor         
Cabinet Médical Recruiting
Toulouse, France, 31000
Principal Investigator: Didier COUSTOU, MD         
Sponsors and Collaborators
Pierre Fabre Dermo Cosmetique
Quanta Medical
Investigators
Principal Investigator: Carle PAUL, Professor Hopital Purpan
  More Information

No publications provided

Responsible Party: Anne-Marie Schmitt, MD, Pierre Fabre Dermo Cosmetiques
ClinicalTrials.gov Identifier: NCT01014637     History of Changes
Other Study ID Numbers: RV4104A 2008 548
Study First Received: November 16, 2009
Last Updated: November 16, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Tunisia: Ministry of Public Health

Keywords provided by Pierre Fabre Dermo Cosmetique:
Dermatomycoses
Infection
Mycoses
Nail diseases
Ski diseases
Skin diseases/infectious

Additional relevant MeSH terms:
Tinea
Onychomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Antifungal Agents
Clotrimazole
Miconazole
Amorolfine
Ciclopirox
Keratolytic Agents
Pharmaceutical Solutions
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents

ClinicalTrials.gov processed this record on August 26, 2014