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Completed

NCT Number: NCT02549001

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

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

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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Polichem Investigative Site, Multiple Locations, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

P-3058 10%

Drug

vehicle of P-3058 10%

Drug

amorolfine 5%

Drug

Other names: Loceryl®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Polichem S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 14, 2015
Registry last updated
Sep 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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