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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:
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00953732
First received: August 4, 2009
Last updated: October 6, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Phase
Actinic Keratosis
 Phase 3

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peplin:

Primary Outcome Measures:
  • Summarize treatment area recurrence of AK lesions, in the selected treatment area [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Summarize long-term safety data(incidence of AEs in the treatment area) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 117
Study Start Date: August 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953732

  Show 42 Study Locations
Sponsors and Collaborators
Peplin
  More Information

Additional Information:
Food and Drug Authority  This link exits the ClinicalTrials.gov site
Therapeutic Goods Administration  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Joseph Suttner, Director, Clinical Development, Peplin
ClinicalTrials.gov Identifier: NCT00953732     History of Changes
Other Study ID Numbers: PEP005-030
Study First Received: August 4, 2009
Last Updated: October 6, 2010
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Peplin:
Peplin
Actinic keratosis
PEP005

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

ClinicalTrials.gov processed this record on May 23, 2013