Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses
NCT ID: NCT00375739
Last Updated: 2016-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
200 participants
INTERVENTIONAL
2006-09-30
2007-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses
NCT00107965
Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel
NCT00239135
A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand
NCT00544297
Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
NCT00659893
A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
NCT00700063
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PEP005
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
3. 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the arm, shoulder, chest, back or scalp.
4. Screening laboratory values within the reference ranges as defined by the central laboratory or "out of range" test results that are clinically acceptable to the Investigator.
5. Ability to follow study instructions and likely to complete all study requirements.
6. Written informed consent has been obtained.
7. Written Authorization for Use and Release of Health and Research Study Information has been obtained.
8. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.
Exclusion
1. Females of child bearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus).
2. Location of the selected AK treatment area:
1. anywhere on the face
2. within 5 cm of an incompletely healed wound
3. on the breast area of women
4. on the dorsum of the hand
3. AK lesions that have atypical clinical appearance e.g. hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on 2 previous occasions), cutaneous horns within the selected AK treatment area.
4. Presence of suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) within the selected AK treatment area or within 10 cm of the selected AK treatment area.
5. Presence of known or suspected metastatic disease.
6. History or evidence of skin conditions other than AK that would interfere with evaluation of the study drug (e.g. eczema, unstable psoriasis, xeroderma pigmentosa).
7. Known sensitivity to any of the ingredients in the study drug.
8. A cosmetic or therapeutic procedure (e.g. use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing):
* within 2 cm of the selected AK treatment area during the 4 weeks prior to screening visit
9. Treatment with 5-fluorouracil, imiquimod, diclofenac, masoprocol or photodynamic therapy:
* within 2 cm of the selected AK treatment area during the 24 months prior to screening visit or
* anywhere during the 4 weeks prior to screening visit
10. Treatment with other immunomodulators (e.g. vinblastine, podophyllin, colhamin, camptothecin), cytotoxic drugs (e.g. cyclophosphamide, azathiopine, chlorambucil, nitrogen mustard, methotrexate), or interferon/ interferon inducers:
* within 4 weeks prior to screening visit
11. Use of acid-containing therapeutic products (e.g. salicylic acids or fruit acids, such as alpha and beta hydroxy acids and glycolic acids), topical retinoids or light chemical peels:
* within 2 cm of the selected AK treatment area during the 4 weeks prior to screening visit
12. Treatment with psoralen plus UVA (PUVA) or use of UVB therapy:
* anywhere during the 6 months prior to screening visit
13. Use of systemic retinoids (e.g. isotretinoin, acitretin, bexarotene):
* within 6 months prior to screening visit
14. Anticipated excessive or prolonged exposure to ultraviolet light (e.g. sunlight, tanning beds).
15. Use of topical salves, artificial tanners or topical steroids:
* On the selected AK treatment area during the 4 weeks prior to screening visit
Exclusion Criteria
18. Uncontrolled systemic disease (e.g. uncontrolled hypertension \[a systolic blood pressure of 180 mmHg or greater and/or a diastolic blood pressure of 110 mmHg or greater\], poorly controlled diabetes \[fasting blood sugar of 350 mg/dl or greater\]).
19. Use of systemic medications that suppress the immune system (e.g. cyclosporine, prednisone, methotrexate, alefacept, infliximab):
* within 4 weeks prior to screening visit
20. Current evidence of chronic alcohol or drug abuse.
21. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study or entry into another investigational drug or device study while enrolled in this study.
22. A condition or situation which in the Investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study \[e.g. patients who required hospitalization in the 2 months prior to screening for an acute or chronic condition\].
23. Selected AK treatment area within 5 cm of an AK lesion previously treated with PEP005, for those patients who have participated in earlier PEP005 topical gel trials. Patients enrolled in Treatment Phase 1 can not be re-enrolled into Treatment Phase 2.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Peplin
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lawrence Anderson, Dr
Role: PRINCIPAL_INVESTIGATOR
Peter Welburn, PhD
Role: STUDY_CHAIR
Sponsor GmbH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Radiant Research
Tucson, Arizona, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Advanced Dermatology and Cosmetic Surgery
Clermont, Florida, United States
Dermatology Associates and Research
Coral Gales, Florida, United States
North Florida Dermatology Associates P.A.
Jacksonville, Florida, United States
Park Avenue Dermatology, PA
Orange Park, Florida, United States
Dermatology Associates of Tallahassee
Tallahassee, Florida, United States
Palm Beach Aesthetics
West Palm Beach, Florida, United States
Medaphase, Inc
Newnan, Georgia, United States
Gwinnett Clinical Research Centre, Inc
Snellville, Georgia, United States
Henry Ford Health Center- Farmington Road
West Bloomfield, Michigan, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
St. Luke's/Roosevelt Hospital Center Dermatology
New York, New York, United States
Mount Sinai Hospital School of Medicine
New York, New York, United States
University Dermatology Consultants, Inc., Dermatology Clinical Research Center
Cincinnati, Ohio, United States
Radiant Research
Columbus, Ohio, United States
Oregon Medical Research
Centre9495 Southwest Locust St., Suite G Portland, Oregon, United States
Radiant Research
Anderson, South Carolina, United States
Radiant Research
Greer, South Carolina, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Dermatology Associates of Tyler
Tyler, Texas, United States
Dermatology Research Centre
Salt Lake City, Utah, United States
Skokane Dermatology Clinic, PLLP.
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PEP005-006
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.