Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00357916
Status:
COMPLETED
Last Update Posted:
2016-04-05
First Post:
2006-07-26
Brief Title:
Study to Determine the Sensitizing Potential of PEP005 Topical Gel in Healthy Volunteers Using a Repeat Insult Patch Test Design
Sponsor:
Peplin
Organization:
Peplin
Study Overview
Official Title:
A Randomized Controlled Study to Evaluate the Sensitizing Potential of PEP005 Topical Gel 001 Concentration in Healthy Volunteers Using a Repeat Insult Patch Test Design
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the sensitisation potential of PEP005 Topical Gel 001 concentration on normal skin
To evaluate skin irritation
To evaluate skin irritation
Detailed Description:
This is a repeat insult patch test study On treatment days the investigational product PEP005 Topical Gel 001 concentration and vehicle control will be applied under open conditions to sites on the infrascapular region of the back 3 times weekly for 3 weeks 9 applications in total during the induction phase Following a rest period of approximatley 10-14 days a single challenge application will be performed Local tolerability will be assessed visually using an ordinal scoring system If a cutaneous response observed in the challenge phase indicates possible sensitisation or at the discretion of the investigator a rechallenge will occur
Study Oversight
Has Oversight DMC:
None
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?:
None