Onychomycosis
Conditions
Keywords
Onychomycosis, Fungal Nail
Brief summary
The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
Detailed description
Healthy, adult volunteers of either sex will be patched on his/her back with AN2690 Solution 2.5%, AN2690 Solution 5%, AN2690 Solution 7.5%, AN2690 Solution Vehicle and Sodium Laurel Sulfate 0.5% over the course of 21 consecutive days. After 24 hours, the patches are to be removed and the site evaluated using a five-point scale for irritation.
Interventions
DRUGAN2690
AN2690 Solution, 2.5%, Daily for up to 21 days
OTHERAN2690 Solution, Vehicle
AN2690 Solution, Vehicle, Daily for up to 21 days
OTHERSodium Lauryl Sulfate, 0.5%
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
Sponsors
Pfizer
Study design
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy, volunteers of either sex, at least 18 years of age or older * Females of childbearing potential submitted to a urine pregnancy test and had negative results at Day 1 and at the final visit and also was using an effective method of birth control (e.g. abstinence, implants, injectables, oral contraceptives, intrauterine contraceptive devices or double barrier) or agreed to use an effective method of birth control prior to becoming sexual active * Subjects were of any skin type or race providing their degree of pigmentation did not interfere with making readings of skin reactions * Subjects were willing to follow the study procedures and complete the study * Written informed consent was obtained
Exclusion criteria
* Subject with any skin disease that would have in any way confounded interpretation of the study results. Atopic dermatitis/eczema, psoriasis or chronic asthma were excluded * Subject was pregnant or nursing * Subject had a history of sensitivity to any component of any of the formulations * Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severe irritation (Grade 3 or 4) observed at any site | Daily for 21 days |
Countries
United States
Outcome results
None listed