Safety and Tolerability Study of ZEP-3 Cream (0.1% and 1.0%), Administered Topically In Healthy Volunteers

Healthy Clinical Trial

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.

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT01863160
• Study type: Interventional
• Source: Shulov Innovate for Science Ltd. 2012
• Status: Completed
• Phase: Phase 1
• Start date: July 2013
• Completion date: February 2014