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
  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:


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:
No publications provided by Peplin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 15, 2014