Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-22 @ 12:06 PM
Study NCT ID:
NCT01863160
Status:
COMPLETED
Last Update Posted:
2014-02-20
First Post:
2013-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability Study of ZEP-3 Cream (0.1% and 1.0%), Administered Topically In Healthy Volunteers
Sponsor:
Shulov Innovate for Science Ltd. 2012
Organization:
Study Overview
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
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: