- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00679523
Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Chihuahua, Mexico
- Unidad de Investigación en Salud (UIS)
-
Guadalajara, Mexico
- Hospital "Dr. Angel Leaño"
-
Guadalajara, Mexico
- Instituto Dermatologico Jalisciense
-
Mexico City, Mexico
- Centro Dermatologico Pascua
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Mexico City, Mexico
- CIF-BIOTEC Medica Sur.
-
Mexico City, Mexico
- IMIC
-
Monterrey, Mexico
- Hospital Universitario Dr. Jose Eleuterio Gonzalez
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Monterrey, Mexico
- MIRC / OCA Hospital
-
Toluca, Mexico
- ISSEMYM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Witnessed, signed informed consent approved by Ethics Committee
- 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
- Subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount from that nail
- Onychomycosis involving 20-60% of the affected great toenail as determined by visual inspection after the nail has been trimmed
- The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed <3 mm
- 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
- Normal or not clinically significant screening safety labs
Exclusion Criteria:
- 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
- Diabetes mellitus requiring treatment other than diet and exercise
- Subjects with chronic moccasin type of T. pedis
- Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis
- 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.
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
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
- Treatment of any type for cancer within the last 6 months
- History of any significant internal disease
- Subjects with a medical history of current or past psoriasis of the skin and/or nails
- Concurrent lichen planus
- 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
- Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary disorders, onychogryphosis, trauma to the nail(s) to be treated
- AIDS or AIDS related complex
- History of street drug or alcohol abuse
- Any subject not able to meet the study attendance requirements
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group 1
AN2690 Solution, 5.0%
|
Once daily application for 180 days
|
EXPERIMENTAL: Group 2
AN2690 Solution, 7.5%
|
Once daily application for 180 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
A calculated endpoint of treatment response at Day 180 comprised of the ISGA, clear nail growth and fungal culture results
Time Frame: Day 180
|
Day 180
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mycological and clinical response of "complete responders", "partial responders", and "non-responder".
Time Frame: Days 180
|
Days 180
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AN2690-ONYC-201 Cohort 1 and 2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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