Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00116649
Status:
COMPLETED
Last Update Posted:
2010-07-20
First Post:
2005-06-30
Brief Title:
Open-Label Safety Study to Evaluate Imiquimod Cream 5 for Large Areas of Actinic Keratosis
Sponsor:
Graceway Pharmaceuticals LLC
Organization:
Graceway Pharmaceuticals LLC
Study Overview
Official Title:
Open-Label Safety and Pharmacokinetic Study of AldaraTM Imiquimod Cream 5 for One Two or Three Treatment Cycles to Surface Areas Greater Than 25 cm2 With Actinic Keratosis
Status:
COMPLETED
Status Verified Date:
2010-07
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:
Actinic keratosis AK is a skin condition that shows up on skin routinely exposed to the sun such as the face scalp shoulders chest back arms and hands The purpose of this study is to evaluate the safety of one two or three cycles of imiquimod for the treatment of AK The AK lesions treated can be in adjacent and nonadjacent areas of the head torso and extremities The total surface area for the AK lesions must be greater than 25 cm2 The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK
Detailed Description:
This was a Phase 4 open-label single-arm multicenter study in male and female subjects aged 18 years or older with clinically diagnosed AK lesions conducted at 31 investigational sites in the United States
This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging from one packet 125 mg to 6 packets 75 mg to either single or multiple body regions for up to 3 cycles depending upon treatment success and AK lesion recurrence Eligible subjects applied imiquimod 5 cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical visible discrete nonhypertrophic AK lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline Multiple treatment areas could be exposed ie head torso andor extremities with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area up to a maximum of 6 packets per dose In each treatment cycle dosing was to continue for 16 weeks approximately 4 months as instructed by the investigator followed by a 2-month treatment-free follow-up period
This study assessed the safety of imiquimod as a treatment for AK applied in doses ranging from one packet 125 mg to 6 packets 75 mg to either single or multiple body regions for up to 3 cycles depending upon treatment success and AK lesion recurrence Eligible subjects applied imiquimod 5 cream prior to normal sleeping hours 2 days per week to at least 4 clinically typical visible discrete nonhypertrophic AK lesions in contiguous or noncontiguous treatment areas totaling greater than 25 cm2 at baseline Multiple treatment areas could be exposed ie head torso andor extremities with the number of packets determined by the investigator but not to exceed one packet for each 25 cm2 treatment area up to a maximum of 6 packets per dose In each treatment cycle dosing was to continue for 16 weeks approximately 4 months as instructed by the investigator followed by a 2-month treatment-free follow-up period
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