Actinic KeratosisPhase 2NCT00375739
Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses
A Phase 2 study testing PEP005 in people with Actinic Keratosis, run by Peplin at 24 sites in United States.
Trial summary
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- PEP005
- How many people
- 200 participants
- Where
- 24 sitesUnited States
- Study dates
- Sep 2006to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients at least 18 years of age.
- Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
- 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.
- 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.
- Ability to follow study instructions and likely to complete all study requirements.
- Written informed consent has been obtained.
- Written Authorization for Use and Release of Health and Research Study Information has been obtained.
- 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.
Who cannot join
- 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).
- Location of the selected AK treatment area:
- anywhere on the face
- within 5 cm of an incompletely healed wound
- on the breast area of women
- on the dorsum of the hand
Show all 36Show fewer
- 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.
- 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.
- Presence of known or suspected metastatic disease.
- 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).
- Known sensitivity to any of the ingredients in the study drug.
- 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
- 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
- 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
- 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
- Treatment with psoralen plus UVA (PUVA) or use of UVB therapy:
- anywhere during the 6 months prior to screening visit
- Use of systemic retinoids (e.g. isotretinoin, acitretin, bexarotene):
- within 6 months prior to screening visit
- Anticipated excessive or prolonged exposure to ultraviolet light (e.g. sunlight, tanning beds).
- Use of topical salves, artificial tanners or topical steroids:
- On the selected AK treatment area during the 4 weeks prior to screening visit
- Anticipated need for hospitalization (in-patient) or surgery (except that specified in exclusion criteria 8) during the study.
- Concurrent disease that suppresses the immune system (e.g. HIV, hepatitis).
- 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]).
- Use of systemic medications that suppress the immune system (e.g. cyclosporine, prednisone, methotrexate, alefacept, infliximab):
- within 4 weeks prior to screening visit
- Current evidence of chronic alcohol or drug abuse.
- 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.
- 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].
- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Academic Dermatology Associates
Albuquerque, New Mexico, 87106-5239
Radiant Research
Anderson, South Carolina, 29621
Oregon Medical Research
Centre9495 Southwest Locust St., Suite G Portland, Oregon, 97223
University Dermatology Consultants, Inc., Dermatology Clinical Research Center
Cincinnati, Ohio, 45219-4215
Advanced Dermatology and Cosmetic Surgery
Clermont, Florida, 34711
Radiant Research
Columbus, Ohio, 43212
Dermatology Associates and Research
Coral Gales, Florida, 33134
Radiant Research
Greer, South Carolina, 29651
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, 35801
North Florida Dermatology Associates P.A.
Jacksonville, Florida, 32204
St. Luke's/Roosevelt Hospital Center Dermatology
New York, New York, 10025
Mount Sinai Hospital School of Medicine
New York, New York, 10029
Medaphase, Inc
Newnan, Georgia, 30263
Park Avenue Dermatology, PA
Orange Park, Florida, 32073
Dermatology Research Centre
Salt Lake City, Utah, 84124
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229-3409
Gwinnett Clinical Research Centre, Inc
Snellville, Georgia, 30078-3250
Skokane Dermatology Clinic, PLLP.
Spokane, Washington, 99204
Dermatology Associates of Tallahassee
Tallahassee, Florida, 32308
Radiant Research
Tucson, Arizona, 85710
Dermatology Associates of Tyler
Tyler, Texas, 75703
Henry Ford Health Center- Farmington Road
West Bloomfield, Michigan, 48322
Palm Beach Aesthetics
West Palm Beach, Florida, 33401
About this study
Official title: A Multi-center, Randomized, Double-blind, Double-dummy, Vehicle-controlled Sequential Cohort Study to Determine the Safety PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses.
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.
Read the detailed description
Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.
- Conditions
- Actinic Keratosis
- Being tested
- PEP005
- Keywords
- Actinic Keratosis, Topical, Solar Keratosis, Sun Spots, Dermatology
- Medical subject headings
- Keratosis, Actinic, Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP005Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Secondary outcomes (1)
Resolution of AK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Peplin
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lawrence Anderson, Dr, Principal investigatorPeter Welburn, PhD, Study chair, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375739
- Sponsor's protocol ID
- PEP005-006
- Status last verified
- Jan 2016
- First submitted
- 11 Sep 2006
- Last updated
- 28 Jan 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Double-dummy, Vehicle-controlled Sequential Cohort Study to Determine the Safety PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses.
- ClinicalTrials.gov ID
- NCT00375739
- Acronym / sponsor ID
- PEP005-006
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, Topical, Solar Keratosis, Sun Spots, Dermatology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- PeplinIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 13 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.
Detailed description
Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male patients at least 18 years of age.
- Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
- 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.
- 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.
- Ability to follow study instructions and likely to complete all study requirements.
Key exclusion criteria (36 listed)
- 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).
- Location of the selected AK treatment area:
- 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.
- 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.
- Presence of known or suspected metastatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP005 | Drug | – |
Primary outcome
Safety
1 secondary outcome
Resolution of AK
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Anderson, Dr principal investigator
Peter Welburn, PhD study chair
Sponsor GmbH
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEP005 in people with Actinic Keratosis, run by Peplin at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2016.