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Trial record 1 of 1 for:    NCT01278394
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Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

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ClinicalTrials.gov Identifier: NCT01278394
Recruitment Status : Completed
First Posted : January 17, 2011
Results First Posted : August 15, 2014
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 14, 2011
First Posted Date  ICMJE January 17, 2011
Results First Submitted Date  ICMJE July 25, 2014
Results First Posted Date  ICMJE August 15, 2014
Last Update Posted Date December 6, 2018
Study Start Date  ICMJE March 2007
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360 [ Time Frame: Day 360 ]
Proportion of subjects with a clinical assessment of a clear (completely normal) nail unit plus a negative fungal culture from the treatment-targeted toenail at Day 360.
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2011)
Clinical Evidence of Complete Clearance of the Treatment-targeted Great Toenail Plus a Negative Fungal Culture at Day 360 [ Time Frame: Day 360 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
  • Clear Nail Growth of the Targeted Toenail [ Time Frame: Day 360 ]
    Clear nail was measured on digital images as the distance in millimeters from the proximal nail fold to the proximal limit of the disease as marked by the Investigator. New Clear Nail Growth (CNG) was calculated from the clear nail measurements.
  • Mycological Evaluations (Negative Potassium Hydroxide (KOH) and Negative Fungal Culture) Compared to Baseline [ Time Frame: Day 90 ]
    Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
  • Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline [ Time Frame: Day 180 ]
    Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
  • Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline [ Time Frame: Day 270 ]
    Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
  • Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline [ Time Frame: Day 360 ]
    Number of subjects with negative KOH, and number of subjects with negative fungal cultures.
  • Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG [ Time Frame: Baseline to 360 ]
    Length of time to clinical evaluation of clear or at least 5 mm of CNG.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2011)
  • Clear Nail Growth of the Targeted Toenail [ Time Frame: Day 360 ]
  • Mycological Evaluations (Negative KOH and Negative Fungal Culture) Compared to Baseline [ Time Frame: Day 90, 180, 270 and 360 ]
  • Length of Time to Clinical Evaluation of Clear or at Least 5 mm of CNG [ Time Frame: Baseline, Days, 14, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 and 360 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail
Official Title  ICMJE An Open-Label, Rising Multiple-Dose, Multi-Center Study to Evaluate the Safety and Efficacy of Topically Applied AN2690 5.0% and 7.5% Solution for the Treatment of Adult Subjects With Onychomycosis of the Great Toenail
Brief Summary The purpose of the study is to determine the safety and efficacy of 5.0% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.
Detailed Description

In this cohort, only the targeted great toenail identified at Baseline prior to the commencement of treatment from culture results collected at the Screening visit were evaluated for primary efficacy whereas all treated toenails were evaluated for safety. At each visit, the investigator was asked to make a clinical evaluation of the targeted great nail, marking whether or not they considered the nail to be clear of onychomycosis. This evaluation was the basis for determining whether or not study medication should be dispensed at the visit.

This record includes information only for Cohort 3 (5% solution) of the study. Cohorts 1 and 2, are described in NCT00679523 (7.5% solution). No comparison was made between Cohorts 1&2 and Cohort 3.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Onychomycosis
Intervention  ICMJE Drug: AN2690 Solution, 5.0%
Once daily application for 360 days
Study Arms  ICMJE Experimental: Group 1
AN2690 Solution, 5.0%
Intervention: Drug: AN2690 Solution, 5.0%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2011)
29
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects must meet all of the following criteria to be included in the study:
  2. Witnessed, signed informed consent approved by Ethics Committee.
  3. Male or female subjects of any race at least 18 years of age but not older than 65 years of age at the time of screening.
  4. For Cohorts 1 and 2, subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount from that nail. For Cohort 3, subjects must have a diagnosis of onychomycosis of at least one great toenail and a positive KOH wet mount AND fungal culture from that nail.
  5. Onychomycosis involving 20-60% of the affected great toenail as determined by visual inspection after the nail has been trimmed.
  6. The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed <3 mm.
  7. Affected great toenail to be treated is capable of re-growth as documented by history or recent observation of at least 2 mm of growth.
  8. Normal or not clinically significant screening safety labs.

Exclusion Criteria:

  1. Females of childbearing potential not using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study.
  2. Diabetes mellitus requiring treatment other than diet and exercise.
  3. Subjects with chronic moccasin type of T. pedis.
  4. Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis.
  5. Subjects unwilling to refrain from the use of nail cosmetics such as clear and or colored nail lacquers from the screening visit until the end of the study.
  6. Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications:

    • Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks
    • Anti-inflammatories, corticosteroids, topical immunomodulators: 2 weeks
  7. Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications:

    • Corticosteroids (including intramuscular injections): 2 weeks
    • Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophytes: 24 weeks
    • Systemic immunomodulators: 4 weeks
  8. Treatment of any type for cancer within the last 6 months.
  9. History of any significant internal disease.
  10. Subjects with a medical history of current or past psoriasis of the skin and/or nails.
  11. Concurrent lichen planus.
  12. Subjects who are known to be allergic to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure.
  13. Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary disorders, onychogryphosis, trauma to the nail(s) to be treated.
  14. AIDS or AIDS related complex.
  15. History of street drug or alcohol abuse.
  16. Any subject not able to meet the study attendance requirements.
  17. Subjects who have participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01278394
Other Study ID Numbers  ICMJE AN2690-ONYC-201
AN2690-ONYC-201 Cohort 3 ( Other Identifier: Anacor )
C3371009 ( Other Identifier: Pfizer )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pfizer
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP