Status:
COMPLETED
Safety and Tolerability Study of ZEP-3 Cream (0.1% and 1.0%), Administered Topically In Healthy Volunteers
Lead Sponsor:
Shulov Innovate for Science Ltd. 2012
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
It is a phase I randomized, double blind, placebo-controlled, dose-escalating study to assess safety, tolerability and pharmacokinetics (PK) data of 0.1% and 1.0% ZEP-3 cream, administered topically u...
Detailed Description
The primary endpoints of this study are: * Safety evaluation - To demonstrate ZEP-3 cream safety in terms of skin irritation score. * Safety evaluation - To demonstrate ZEP-3 cream safety in terms of...
Eligibility Criteria
Inclusion
- Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
- Subject, either men or women is between 18 and 50 years of age.
- Subject, Body mass index (BMI) is within the normal to overweight range (See appendix 2)
- Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test article
- Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
- Subject is willing to participate in the study and adhere to the study protocol
- Females of childbearing potential should either be surgically sterile, or should use a highly effective medically accepted contraceptive regimen.
Exclusion
- Subject has hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields
- Dark skinned persons whose skin color prevents ready assessment of skin reactions
- Subject with history of skin disorders or any active skin condition involving the test fields including but not limited to bacterial, viral, or fungal skin infections, acne, rosacea
- UV therapy or significant UV exposure in the four weeks before treatment application
- Subject with renal failure (Cr \> 2 mg/dl) or Subject with impaired hepatic function (ALT, AST 2-fold higher than normal upper limit value).
- Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
- Subject suffers from an autoimmune disease (Diabetes, Lupus. Chron ect.)
- History of malignancy
- Sever illness or surgery within the previous 3 months (except for minor cosmetic or dental procedures)
- Treatment with any investigational agent in another clinical trial within 1 month prior to start of this study.
- Female subject who is pregnant , lactating, or with a positive pregnancy test
- History of drug or alcohol abuse (as defined by the Investigator)
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01863160
Start Date
July 1 2013
End Date
February 1 2014
Last Update
February 20 2014
Active Locations (1)
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1
Sheba Medical Center
Ramat Gan, Israel, 52621