Clinical trial NCT01863160: Safety and Tolerability Study of ZEP-3 Cream (0.1% and 1.0%), Administered Topically In Healthy Volunteers
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetic profile
ZEP-3 Cream (0.1% and 1.0%)
administered topically
Lead sponsor: Shulov Innovate for Science Ltd. 2012
Sponsor class: INDUSTRY
First posted: 2013-05-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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 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.

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

Eligibility criteria: Inclusion Criteria:

1. Subject must voluntarily sign and date the written Informed Consent prior to any study specific procedures
2. Subject, either men or women is between 18 and 50 years of age.
3. Subject, Body mass index (BMI) is within the normal to overweight range (See appendix 2)
4. Subject must have healthy skin on which reddening can be easily recognized in the area where they will place the test article
5. Subject must be free from a condition/disease that the investigator feels interferes with the interpretation of the study results.
6. Subject is willing to participate in the study and adhere to the study protocol
7. Females of childbearing potential should either be surgically sterile, or should use a highly effective medically accepted contraceptive regimen.

Exclusion Criteria:

1. Subject has hyper- or hypo-pigmentation, or tattoos in the area where they will place the test fields
2. Dark skinned persons whose skin color prevents ready assessment of skin reactions
3. 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
4. UV therapy or significant UV exposure in the four weeks before treatment application
5. Subject with renal failure (Cr \> 2 mg/dl) or Subject with impaired hepatic function (ALT, AST 2-fold higher than normal upper limit value).
6. Cardiac disease, including recent myocardial infarction, any degree of heart block or other cardiac arrhythmias and valvular heart disease
7. Subject suffers from an autoimmune disease (Diabetes, Lupus. Chron ect.)
8. History of malignancy
9. Sever illness or surgery within the previous 3 months (except for minor cosmetic or dental procedures)
10. Treatment with any investigational agent in another clinical trial within 1 month prior to start of this study.
11. Female subject who is pregnant , lactating, or with a positive pregnancy test
12. History of drug or alcohol abuse (as defined by the Investigator)

Primary outcomes:
measure: Topical skin safety evaluation
timeFrame: Change in skin clinical presentation up to 5 consecutive treatment days
Secondary outcomes:
measure: Systemic absorption
timeFrame: During 24 hours following initial application
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Aviv Barzily, PhD
role: PRINCIPAL_INVESTIGATOR
References: