Actinic KeratosisPhase 2NCT00544297
A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand
A Phase 2 study testing PEP005 gel in people with Actinic Keratosis, run by Peplin at 4 sites in United States.
Trial summary
The purpose of this study is to examine the safety and toleration of PEP005 Topical Gel, administered on an actinic keratosis (AK) treatment area on the top of a hand. 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 gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2007to Jan 2008
- 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
- 4 to 8 clinically typical, visible and discrete AK lesions within an area on the dorsum of one hand.
- Written informed consent 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
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Dermatology Clinical Research Centre of San Antonio
San Antonio, Texas, 78229-3409
Skin Surgery Medical Group Inc
San Diego, California, 92117
Gwinnett Clinical Research Centre
Snellville, Georgia, 30078-3250
Dermatology Associates of Tyler
Tyler, Texas, 75703
About this study
Official title: A Multi-center, Open-label Study to Examine the Safety and Toleration of 0.05% PEP005 Topical Gel in Patients With Actinic Keratoses on the Dorsum of the Hand
The purpose of this study is to examine the safety and toleration of PEP005 Topical Gel, administered on an actinic keratosis (AK) treatment area on the top of a hand.
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 gel
- Keywords
- Actinic Keratosis, Topical, Dermatology, Hand
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP005 gelDrug
Also called PEP005
Two day application, 0.05%
| Study group | Role | What they receive |
|---|---|---|
| PEP005 gel administration | Experimental | 0.05% PEP005 Topical Gel administered for two consecutive days to a 25cm2 contiguous AK treatment area on the top of the hand Receives: Drug: PEP005 gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR)
Measured: 57 days
Secondary outcomes (1)
The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions.
Measured: 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2008
- Study completionJan 2008
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peplin
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Omnicare Clinical Research
- Responsible party
- Sponsor
- Investigators
- Arthur P Bertolino, MD, Study director, Chief Medical Officer and VP Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00544297
- Sponsor's protocol ID
- PEP005-018
- Status last verified
- Mar 2015
- First submitted
- 14 Oct 2007
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label Study to Examine the Safety and Toleration of 0.05% PEP005 Topical Gel in Patients With Actinic Keratoses on the Dorsum of the Hand
- ClinicalTrials.gov ID
- NCT00544297
- Acronym / sponsor ID
- PEP005-018
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, Topical, Dermatology, Hand
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PeplinIndustry (pharma, biotech, devices)
- Collaborators
- Omnicare Clinical Research
- Study start
- Oct 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 16 Oct 2007 (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 examine the safety and toleration of PEP005 Topical Gel, administered on an actinic keratosis (AK) treatment area on the top of a hand.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEP005 gel administration | Experimental | Drug: PEP005 gel0.05% PEP005 Topical Gel administered for two consecutive days to a 25cm2 contiguous AK treatment area on the top of the hand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients at least 18 years of age.
- Post-menopausal female patients
- 4 to 8 clinically typical, visible and discrete AK lesions within an area on the dorsum of one hand.
- Written informed consent 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.
Key exclusion criteria (0 listed)
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 gelAlso: PEP005Two day application, 0.05% | Drug | PEP005 gel administration |
Primary outcome
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR)
Time frame: 57 days
1 secondary outcome
The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions.
Time frame: 57 days
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 2 Apr 2015.
- Food and Drug AdministrationLink provided by the sponsor.
- Human Research Ethics CommitteeLink provided by the sponsor.
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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.
Arthur P Bertolino, MD study director
Chief Medical Officer and VP Medical Affairs
4 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 gel in people with Actinic Keratosis, run by Peplin at 4 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 5 inclusion and 0 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 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR) (time frame: 57 days). 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 2 Apr 2015.