- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01863160
Safety and Tolerability Study of ZEP-3 Cream (0.1% and 1.0%), Administered Topically In Healthy Volunteers
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-escalating Study to Assess Safety, Tolerability and Pharmacokinetics of 0.1% and 1.0% ZEP-3 Cream, Administered Topically in Healthy Volunteers.
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 up to 5 consecutive treatment days in healthy volunteers.
This is a single center trial. It is anticipated that the study will be conducted at the Department of Dermatology, at the Sheba Medical Center, Ramat Gan, Israel.
The screening/enrollment visit includes a PK study for 24h following a single IP topical application. After a 24h washout time break, the subject will enter the treatment period for 5 consecutive treatment days followed by a follow up visit 1 and 5 days after end of treatment.
Study Overview
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 type and severity of reported adverse events.
- Tolerability evaluation - To demonstrate ZEP-3 cream tolerability in terms of treatment compliance by the treated volunteers.
The secondary endpoints of this study are:
- Systemic absorption PK profile.
- Dermal absorption PK profile (Optional).
Subject safety will be assessed following treatment by ZEP-3 cream, using measurements of the following variables:
- Dermal reaction parameters
- Physical examination
- Vital Signs (HR, BP, RR, Body temperature)
- 12 lead ECG data
- Laboratory tests (CBC, blood chemistry, coagulation functions, urinalysis)
- Adverse events recording
- Change in concomitant medications
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ramat Gan, Israel, 52621
- Sheba Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 0.1% ZEP-3 cream
250 mg of ZEP-3 Cream 0.1% is applied on the right ventral forearm and 250 mg placebo is applied on the left ventral forearm 4 times daily
|
Topical application of 250mg ZEP-3 cream (0.1%) vs. placebo 4 times daily The IP is applied to "in advanced" demarcated sites in a dose escalating mode to 3 different treatment area sizes: small area of 2x1 cm (2 cm2), medium area of 2x5 cm (10 cm2), and large area of 4x5 cm (20 cm2). The IP ZEP-3 cream will be applied on both ventral forearms (one application site per forearm) in a non-occlusive mode, spread and rubbed over the demarcated area.
Other Names:
|
OTHER: placebo
250 mg of ZEP-3 Cream 1.0% is applied on the right ventral forearm and 250 mg placebo is applied on the left ventral forearm 4 times daily
|
Topical application of 250mg ZEP-3 cream (1.0%) vs. placebo 4 times daily The IP is applied to "in advanced" demarcated sites in a dose escalating mode to 3 different treatment area sizes: small area of 2x1 cm (2 cm2), medium area of 2x5 cm (10 cm2), and large area of 4x5 cm (20 cm2). The IP ZEP-3 cream will be applied on both ventral forearms (one application site per forearm) in a non-occlusive mode, spread and rubbed over the demarcated area. Right arm, single treatment area - ZEP-3 (1.0%) Left arm, single treatment area - Placebo cream
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Topical skin safety evaluation
Time Frame: Change in skin clinical presentation up to 5 consecutive treatment days
|
Skin irritation
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Change in skin clinical presentation up to 5 consecutive treatment days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systemic absorption
Time Frame: During 24 hours following initial application
|
PK profile
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During 24 hours following initial application
|
Collaborators and Investigators
Investigators
- Principal Investigator: Aviv Barzily, PhD, Sheba Medical Center
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 (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ZEP - 001 - IL
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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