A Long Term Follow up Study of Patients Who Have Completed the PEP005-020 Study

This study has been completed.
Sponsor:
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00952783
First received: August 4, 2009
Last updated: October 6, 2010
Last verified: October 2010

August 4, 2009
October 6, 2010
July 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 ] [ Designated as safety issue: No ]
Summarize treatment area recurrence of Actinic Keratosis lesions, in the selected treatment area for patients who have completed Day 57 in study PEP005-020 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00952783 on ClinicalTrials.gov Archive Site
Summarize long-term safety data (incidence of adverse events in the treatment area) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Summarize long-term safety data, in the selected treatment area, for patients who have completed Day 57 in study PEP005-020 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Long Term Follow up Study of Patients Who Have Completed the PEP005-020 Study
A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on Non-head Areas (Trunk and Extremities) Who Have Completed Day 57 in Study PEP005-020

This study is designed to follow up patients, who have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in the PEP005-020 study, over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients who have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in study PEP005-020

Actinic Keratosis
Not Provided
1
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
98
October 2010
October 2010   (final data collection date for primary outcome measure)

Inclusion

  • Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures
  • Patient achieved complete clearance of AK lesions (lesion count of 0) in the selected treatment area at the Day 57 visit in study PEP005-020

Exclusion

  • 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 PEP005-020
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00952783
PEP005-031
No
Janelle Katsamas, Peplin
Peplin
Not Provided
Not Provided
Peplin
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP