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NCT Number: NCT00253305

Topical Gel Anti-Fungal Agent for Tinea Unguium

The purpose of this study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of subjects with distal subungual tinea unguium of the toenails (onychomycosis).

The formulation used as the vehicle for the active agents has been shown in earlier studies to facilitate the penetration of the active agent through fungally-infected nails. This study will examine dose-response and agent differences in terms of efficacy and safety.

Once the subject has qualified for the study, he/she will be randomly assigned to one of five study groups, dispensed appropriate study medication and instructed to apply one drop to the great toe designated for study.

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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

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • clinical diagnosis of distal subungual tinuea unguium of one great toenail.
  • between 20 - 65% infected area for target nail
  • 2 mm of clear nail proximally on target nail
  • positive dermatophyte culture and positive KOH test
  • able to sign informed consent
  • understand requirements of study
  • females must be post-menopausal or agree to use approved contraceptives throughout the study

Exclusion criteria

  • patients with nails infected with organisms other than dermatophytes
  • patients with proximal subungual tinea unguium
  • patients with spikes of disease extending to nail matrix
  • patients with more than 5 infected nails
  • patients with confounding problems/ abnormalities of target nail
  • patients with screening lab values more than 20% of normal
  • patients with known hypersensitivity to test material components
  • patients requiring systemic medications that may interfere with study
  • patients with a poor history of compliance with study requirements

Treatment and study plan

Organogel of naftifine, 2%

Drug

Organogel of terbinafine, 2%

Drug

Organogel of naftifine, 6%

Drug

Organogel of terbinafine, 6%

Drug

Primary outcomes

  1. Quanitative improvement in toenail appearance.

  2. Assessment of dermatophyte culture and KOH examination.

  3. Frequency and severity of adverse events.

Secondary outcomes

  1. Time to achieve 90% and 100% clearance of fungus from nail.

  2. Assessment of treatment success.

  3. Assessment of mycological success.

Sponsors and collaborators

Lead sponsor

MediQuest Therapeutics

Industry

Registry information

Official study title

Phase IIB Efficacy and Safety Study of Four Topical Gel Formulations of Anti-Fungal Agents, MQX-5858, MQX-5859, MQX-5866, and MQX-5867, Versus Vehicle in the Treatment of Tinea Unguium.

Important dates

Study start
2005
First posted
Nov 15, 2005
Registry last updated
May 30, 2007

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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