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

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ClinicalTrials.gov Identifier: NCT00953732
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : March 26, 2015
Sponsor:
Collaborator:
TKL Research, Inc.
Information provided by (Responsible Party):
Peplin

Brief Summary:
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.

Condition or disease Intervention/treatment
Actinic Keratosis Drug: Lesion count

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 117 participants
Time Perspective: Prospective
Official Title: 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)
Study Start Date : August 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
1 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




Primary Outcome Measures :
  1. Summarize treatment area recurrence of AK lesions, in the selected treatment area [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Summarize long-term safety data(incidence of AEs in the treatment area) [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00953732


  Show 42 Study Locations
Sponsors and Collaborators
Peplin
TKL Research, Inc.
Investigators
Study Director: Eugene Bauer, MD Chief Medical Officer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00953732     History of Changes
Other Study ID Numbers: PEP005-030
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Peplin:
Peplin
Actinic keratosis
PEP005

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms