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Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis

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ClinicalTrials.gov Identifier: NCT02549001
Recruitment Status : Completed
First Posted : September 14, 2015
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Polichem S.A.

Brief Summary:
The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.

Condition or disease Intervention/treatment Phase
Onychomycosis Drug: P-3058 10% Drug: vehicle of P-3058 10% Drug: amorolfine 5% Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 953 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Parallel, Vehicle-controlled Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Onychomycosis
Actual Study Start Date : August 20, 2015
Actual Primary Completion Date : September 17, 2018
Actual Study Completion Date : September 17, 2018

Arm Intervention/treatment
Experimental: P-3058 10%
P-3058 10%
Drug: P-3058 10%
Placebo Comparator: vehicle of P-3058 10%
vehicle of P-3058 10%
Drug: vehicle of P-3058 10%
Active Comparator: amorolfine 5%
Loceryl®
Drug: amorolfine 5%
Other Name: Loceryl®




Primary Outcome Measures :
  1. Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear. [ Time Frame: Week 60 ]

Secondary Outcome Measures :
  1. Responder rate of the target toenail, defined as negative KOH microscopy, negative culture for dermatophytes and ≤10% residual involvement of the target toenail. [ Time Frame: Week 60 ]
  2. Negative culture rate for dermatophytes of the target nail. [ Time Frame: Week 60 ]
  3. Mycological cure defined as negative KOH microscopy and negative culture for dermatophytes of the target nail. [ Time Frame: Week 60 ]
  4. Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation. [ Time Frame: Week 60 ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent
  • Patients aged 12 years and older of any race.
  • Males or females.
  • Patients with onychomycosis involving ≥ 20% to ≤ 50% of target big toenail.
  • Patients with a positive KOH examination and culture positive for dermatophyte

Exclusion Criteria:

  • Presence of "yellow spikes" on the target nail.
  • Presence of dermatophytoma on the target nail.
  • Presence of nail thickness exceeding 2 mm.
  • Patients with proximal subungual involvement
  • Patients with severe plantar or moccasin tinea pedis
  • Patients with nail abnormalities due to other conditions
  • Patients with life expectancy less than 2 years.
  • Chemotherapy, immunosuppressive therapy in the 12 weeks prior to Screening visit (V1).
  • Systemic corticosteroids, antimetabolites and immune-stimulants therapy in the 4 weeks prior to Screening visit (V1).
  • HIV infection or any other immunodeficiency.
  • Alcohol or substance abuse.
  • Patients with history of allergic reactions to terbinafine or its excipients.
  • Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549001


Locations
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Belgium
Polichem Investigative Site
Multiple Locations, Belgium
Bulgaria
Polichem Investigative Site
Multiple Locations, Bulgaria
Czechia
Polichem Investigative Site
Multiple Locations, Czechia
Germany
Polichem Investigative Site
Multiple Locations, Germany
Greece
Polichem Investigative Site
Multiple Locations, Greece
Hungary
Polichem Investigative Site
Multiple Locations, Hungary
Iceland
Polichem Investigative Site
Various Cities In Iceland, Iceland
Latvia
Polichem Investigative Site
Multiple Locations, Latvia
Lithuania
Polichem Investigative Site
Multiple Locations, Lithuania
Poland
Polichem Investigative Site
Multiple Locations, Poland
Russian Federation
Polichem Investigative Site
Multiple Locations, Russian Federation
Slovakia
Polichem Investigative Site
Multiple Locations, Slovakia
Sweden
Polichem Investigative Site
Multiple Locations, Sweden
Sponsors and Collaborators
Polichem S.A.
Investigators
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Study Director: Maurizio Caserini, MD Polichem S.A.

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Responsible Party: Polichem S.A.
ClinicalTrials.gov Identifier: NCT02549001     History of Changes
Other Study ID Numbers: PM1331
2015-000561-31 ( EudraCT Number )
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Keywords provided by Polichem S.A.:
Onychomycosis
Nail fungus
Additional relevant MeSH terms:
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Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases
Amorolfine
Antifungal Agents
Anti-Infective Agents