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A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00953732
First Posted: August 6, 2009
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
Peplin
August 4, 2009
August 6, 2009
March 26, 2015
August 2009
October 2010   (Final data collection date for primary outcome measure)
Summarize treatment area recurrence of AK lesions, in the selected treatment area [ Time Frame: 12 months ]
Summarize treatment area recurrence of AK lesions, in the selected treatment area for patients who have completed Day 57 in studies PEP005-016 and PEP005-025 [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00953732 on ClinicalTrials.gov Archive Site
Summarize long-term safety data(incidence of AEs in the treatment area) [ Time Frame: 12 months ]
Summarize long-term safety data, in the selected treatment area for patients who have completed Day 57 in studies PEP005-016 and PEP005-025 [ Time Frame: 12 months ]
Not Provided
Not Provided
 
A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies
A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)
This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.
A 12 month long-term follow-up study of patients who have achieved complete clearance of AK lesions at the Day 57 in the Phase 3 studies PEP005-016 or PEP005-025.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
All patients must have achieved complete clearance of AK lesions at Day 57 visit in either study PEP005-016 or PEP005-025 will be offered participation in this study.
Actinic Keratosis
Drug: Lesion count
Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study.
Other Name: AK lesion recurrence
1
Intervention: Drug: Lesion count
Lebwohl M, Shumack S, Stein Gold L, Melgaard A, Larsson T, Tyring SK. Long-term follow-up study of ingenol mebutate gel for the treatment of actinic keratoses. JAMA Dermatol. 2013 Jun;149(6):666-70. doi: 10.1001/jamadermatol.2013.2766.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
117
October 2010
October 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient must have achieved complete clearance of AK lesions (lesion count = 0) at Day 57 in one of the following Peplin AK clinical studies: PEP005-016 or PEP005-025
  • Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures

Exclusion Criteria:

  • Concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous Peplin AK study)
  • Early termination from study PEP005-016 or PEP005-025
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United States
 
 
NCT00953732
PEP005-030
No
Not Provided
Not Provided
Peplin
Peplin
TKL Research, Inc.
Study Director: Eugene Bauer, MD Chief Medical Officer
Peplin
March 2015