Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT00680160
Eligibility Criteria:
Inclusion Criteria:
* A witnessed, signed informed consent approved by Institutional Review Board
* Male or female of any race at least 18 years of age but not older than 65 years of age at the time of screening
* Body Mass Index between 18.5 and 35, inclusive
* Onychomycosis involving \> 80% of both great toenails, as determined by visual inspection after the nail has been trimmed
* Each great toenail possess a combined thickness of the nail plate and nail bed \> 3 mm
* At least six additional toenails with clinical diagnosis of onychomycosis
* A positive KOH wet mount for at least one great toenail
* If subject is a female of childbearing potential, must be using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study
* Considered reliable and capable of understanding his/her responsibility and role in the study
Exclusion Criteria:
* History of allergy 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
* Clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety
* Diabetes mellitus requiring treatment other than diet and exercise
* 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
* Nursing, pregnant or planning to become pregnant during the study
* Has not undergone the specified washout period(s) for the following topical preparations or does the subject require the concurrent use of any of the following topical medications:
1. Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study: 4 weeks
2. Anti-inflammatories, corticosteroids, topical immunomodulators: 2 weeks
* Has not undergone the specified washout period(s) for the following systemic medications or does the subject require the concurrent use of any of the following systemic medications:
1. Corticosteroids (including intramuscular injections): 2 weeks
2. Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophyte: 24 weeks
3. Systemic immunomodulators: 4 weeks
* Received treatment of any type for cancer within the last 6 months
* History of any significant internal disease
* 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
* Donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation
* Donated plasma during the two week period preceding study initiation
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00680160
Study Brief:
Protocol Section:
NCT00680160