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CompletedNCT00952783Updated Mar 26, 2015

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

An observational study in Actinic Keratosis, sponsored by Peplin. Completed at 11 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-26.

Sponsored by Peplin · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
98
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Actinic Keratosis

Keywords

  • Peplin
  • Actinic keratosis
  • PEP005
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In context

Keratosis, Actinic

364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.

This study's enrollment of 98 is below the median of 179 across 35 observational studies indexed under Keratosis, Actinic.

Browse Keratosis, Actinic studies →

Lead sponsor

Peplin is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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 criteria

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
98 participants (actual)

Groups and cohorts

  • 1

    Drug: Lesion count

Interventions

  • DrugLesion count

    Lesion count in area treated by study drug in a prior study over a 12 month period No drug will be applied during this long-term follow up study. Drug was applied during the primary study.

    Also known as: AK lesion recurrence

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What researchers measure

Primary outcomes

  1. Summarize treatment area recurrence of AK lesions in the selected treatment area

    Time frame: 12 months

Secondary outcomes

  1. Summarize long-term safety data (incidence of adverse events in the treatment area)

    Time frame: 12 months

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Study locations

11 sites
  • Park Avenue Dermatology
    Orange Park, Florida 32073, United States
  • Medaphase Inc
    Newnan, Georgia 30263, United States
  • Gwinnett Clinical Research Centre
    Snellville, Georgia 30078-3250, United States
  • Michigan Center for Research Corp
    Clinton Twp, Michigan 48038, United States
  • Henry Ford Health Systems
    Detroit, Michigan 48202, United States
  • Dermatology Associates of Rochester
    Rochester, New York 14623, United States
  • Oregon Health and Science University
    Portland, Oregon 97239-4501, United States
  • Dermatology Research Associates
    Nashville, Tennessee 37203, United States
  • Dematology on Ward
    Adelaide, South Australia 5006, Australia
  • Dermatology Institute of Victoria
    Melbourne, Victoria 3141, Australia
  • St John of God Dermatology
    Subiaco, Western Australia 6008, Australia
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References and documents

Publications

  • 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. PubMed 23553119 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00952783
Lead sponsor
Peplin
Responsible party
Sponsor
First posted
Aug 6, 2009
Start date
Jul 2009
Primary completion
Oct 2010
Completion
Oct 2010
Last update
Mar 26, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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