Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT01863160
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
Study:
NCT01863160
Study Brief:
Protocol Section:
NCT01863160