Actinic KeratosisPhase 2NCT00107965
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses
A Phase 2 study testing PEP005 in people with Actinic Keratosis, run by Peplin at 6 sites in Australia.
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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 6 sitesAustralia
- Study dates
- Mar 2005to Sep 2005
- 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 or female patients
- At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp
Who cannot join
- A cosmetic or therapeutic procedure:
- within 10 cm of the selected AK lesions during the 3 months prior to study entry or
- anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
- Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:
- of lesions located within 10 cm of the selected AK lesions during the 3 months prior to study entry or
- anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
Show all 12Show fewer
- Use of acid-containing products, topical retinoids or light chemical peels within 10 cm of the selected AK lesions during the 3 months prior to study entry, or anticipated treatment in this same area during the study
- Treatment with immuno-modulators, cytotoxic drugs, or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study
- Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study
- Use of systemic retinoids during the 6 months prior to study entry or anticipated treatment during the study
- Anticipated excessive or prolonged exposure to ultraviolet light or use of topical salves, creams or ointments to the selected AK lesions during the study
- Females of childbearing potential
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Australia6 sites
Siller Medical
Brisbane, Queensland, 4000
Fremantle Dermatology
Fremantle, Western Australia, 6160
Private Dermaology Clinic
Fremantle, Western Australia, 6160
Skin and Cancer Foundation
Melbourne, Victoria, 3052
Monash Medical Centre
Melbourne, Victoria, 3168
Royal Prince Alfred Hospital
Sydney, New South Wales, 2050
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Actinic Keratoses
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of actinic keratoses.
- Conditions
- Actinic Keratosis
- Being tested
- PEP005
- Keywords
- Actinic Keratosis, Solar Keratosis, AK, Sun spots, PEP005, Topical, 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
0.0025% PEP005 Topical Gel (Day 1,2 application)
PEP005Drug
0.01% PEP005 Topical Gel (Day 1,2 application)
PEP005Drug
0.05% PEP005 Topical Gel (Day 1,2 application)
PEP005Drug
Vehicle Gel (Day 1,2 application)
PEP005Drug
0.0025% PEP005 Topical Gel (Day 1,8 application)
PEP005Drug
0.01% PEP005 Topical Gel (Day 1,8 application)
PEP005Drug
0.05% PEP005 Topical Gel (Day 1,8 application)
PEP005Drug
Vehicle Gel (Day 1,8 application)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PEP005 |
| 2 | Experimental | Not described Receives: Drug: PEP005 |
| 3 | Experimental | Not described Receives: Drug: PEP005 |
| 4 | Placebo comparator | Not described Receives: Drug: PEP005 |
| 5 | Experimental | Not described Receives: Drug: PEP005 |
| 6 | Experimental | Not described Receives: Drug: PEP005 |
| 7 | Experimental | Not described Receives: Drug: PEP005 |
| 8 | Placebo comparator | Not described Receives: Drug: PEP005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety of PEP005 Topical Gel at 0.0025%, 0.01%, and 0.05% administered as two applications to patients with actinic keratosis (AKs) on the arms, shoulders, chest, face, and/or scalp
Measured: 85 days
Secondary outcomes (1)
To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2005 (estimated)
- Study startMar 2005
- Primary completionSep 2005
- Study completionSep 2005
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Peplin
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Greg Siller, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107965
- Sponsor's protocol ID
- PEP005-001
- Other IDs
- 2005/145
- Status last verified
- Mar 2015
- First submitted
- 11 Apr 2005
- Last updated
- 25 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Actinic Keratoses
- ClinicalTrials.gov ID
- NCT00107965
- Acronym / sponsor ID
- PEP005-001
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, Solar Keratosis, AK, Sun spots, PEP005, Topical, Dermatology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- PeplinIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 12 Apr 2005 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PEP005 |
| 2 | Experimental | Drug: PEP005 |
| 3 | Experimental | Drug: PEP005 |
| 4 | Placebo comparator | Drug: PEP005 |
| 5 | Experimental | Drug: PEP005 |
| 6 | Experimental | Drug: PEP005 |
| 7 | Experimental | Drug: PEP005 |
| 8 | Placebo comparator | Drug: PEP005 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female patients
- At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp
Key exclusion criteria (12 listed)
- A cosmetic or therapeutic procedure:
- Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:
- Use of acid-containing products, topical retinoids or light chemical peels within 10 cm of the selected AK lesions during the 3 months prior to study entry, or anticipated treatment in this same area during the study
- Treatment with immuno-modulators, cytotoxic drugs, or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study
- Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study
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 |
|---|---|---|
| PEP0050.0025% PEP005 Topical Gel (Day 1,2 application) | Drug | 1 |
| PEP0050.01% PEP005 Topical Gel (Day 1,2 application) | Drug | 2 |
| PEP0050.05% PEP005 Topical Gel (Day 1,2 application) | Drug | 3 |
| PEP005Vehicle Gel (Day 1,2 application) | Drug | 4 |
| PEP0050.0025% PEP005 Topical Gel (Day 1,8 application) | Drug | 5 |
| PEP0050.01% PEP005 Topical Gel (Day 1,8 application) | Drug | 6 |
| PEP0050.05% PEP005 Topical Gel (Day 1,8 application) | Drug | 7 |
| PEP005Vehicle Gel (Day 1,8 application) | Drug | 8 |
Primary outcome
To determine the safety of PEP005 Topical Gel at 0.0025%, 0.01%, and 0.05% administered as two applications to patients with actinic keratosis (AKs) on the arms, shoulders, chest, face, and/or scalp
Time frame: 85 days
1 secondary outcome
To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses
Time frame: 85 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 25 Mar 2015.
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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.
Greg Siller principal investigator
6 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 6 sites in Australia.
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 2 inclusion and 12 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 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia. 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. Some participants in this study may receive a placebo. 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?
To determine the safety of PEP005 Topical Gel at 0.0025%, 0.01%, and 0.05% administered as two applications to patients with actinic keratosis (AKs) on the arms, shoulders, chest, face, and/or scalp (time frame: 85 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 25 Mar 2015.