Actinic KeratosisPhase 1NCT00659893
Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
A Phase 1 study testing PEP005 Topical gel in people with Actinic Keratosis, run by Peplin at 13 sites in 2 countries.
Trial summary
Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- PEP005 Topical gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Apr 2008to Nov 2008
- Phase
- Phase 1
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be male and at least 18 years of age.
- A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions.
Who cannot join
- Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 weeks and within 2 cm of the selected treatment area(s).
- Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system: within 4 weeks.
- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and within 2 cm of the selected treatment area(s).
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States8 sites
J&S Studies
College Station, Texas, 77845
Medaphase Inc
Newnan, Georgia, 30263
Park Avenue Dermatology
Orange Park, Florida, 32073
Advanced Dermatology and Cosmetic Surgery
Ormond Beach, Florida, 32174
Radiant Research Inc.
Pinellas Park, Florida, 33781
Karen S. Harkaway, MD LLC
Riverside Park, New Jersey, 08075
Skin Surgery Medical Group Inc.
San Diego, California, 92117
Radiant Research
Tucson, Arizona, 85710
Australia5 sites
South East Dermatology, Belmont Specialist Centre
Carina Heights, Brisbane, Queensland, 4152
Skin and Cancer Foundation
Carlton, Melbourne, Victoria, 3053
St George Dematology and Skin and Cancer Centre
Kogarah, Sydney, New South Wales, 2217
St John of God Dermatology
Subiaco, Perth, Western Australia, 6008
Burswood Dermatology
Victoria Park, Perth, Western Australia, 6100
About this study
Official title: A Multi-center, Open Label, Dose-area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)
Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.
- Conditions
- Actinic Keratosis
- Being tested
- PEP005 Topical gel
- Keywords
- Peplin, PEP005, Actinic Keratosis
- 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 Topical gelDrug
0.05%, two day dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cohort 1 One 25 cm2 treatment area; on one arm Receives: Drug: PEP005 Topical gel |
| 2 | Experimental | Cohort 2 One 50cm2 contiguous treatment area; on one arm Receives: Drug: PEP005 Topical gel |
| 3 | Experimental | Cohort 3 Two 25cm2 treatment areas; one on each arm Receives: Drug: PEP005 Topical gel |
| 4 | Experimental | Cohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm Receives: Drug: PEP005 Topical gel |
| 5 | Experimental | Cohort 5 One 75cm2 contiguous treatment area; on one arm Receives: Drug: PEP005 Topical gel |
| 6 | Experimental | Cohort 6 Two 50cm2 contiguous treatment area; one on each arm Receives: Drug: PEP005 Topical gel |
| 7 | Experimental | Cohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm Receives: Drug: PEP005 Topical gel |
| 8 | Experimental | Cohort 8 One 100cm2 contiguous treatment area; on one arm Receives: Drug: PEP005 Topical gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (incidence of AEs, SAEs and skin responses)
Measured: Screening to End of Study (Day 57)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peplin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Schmieder, DO, Principal investigator, Park Avenue DermatologyStephen Shumack, MD, Principal investigator, St George Dermatology and Skin and Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659893
- Sponsor's protocol ID
- PEP005-022
- Status last verified
- Nov 2008
- First submitted
- 15 Apr 2008
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Anderson L, Jarratt M, Schmieder G, Shumack S, Katsamas J, Welburn P. Tolerability and Pharmacokinetics of Ingenol Mebutate 0.05% Gel Applied to Treatment Areas up to 100cm(2) on the Forearm(s) of Patients with Actinic Keratosis. J Clin Aesthet Dermatol. 2014 Dec;7(12):19-29.
PubMed 25584134
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open Label, Dose-area Escalation, Cohort Study to Evaluate the Safety and Tolerability of 0.05% PEP005 Topical Gel Applied for Two Consecutive Days to Treatment Area(s) of up to a Total of 100 cm2 in Patients With Actinic Keratoses on the Extensor (Dorsal Aspect) Forearm(s)
- ClinicalTrials.gov ID
- NCT00659893
- Acronym / sponsor ID
- PEP005-022
- Conditions
- Actinic Keratosis
- Keywords
- Peplin, PEP005, Actinic Keratosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- PeplinIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 17 Apr 2008 (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.
Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PEP005 Topical gelCohort 1 One 25 cm2 treatment area; on one arm |
| 2 | Experimental | Drug: PEP005 Topical gelCohort 2 One 50cm2 contiguous treatment area; on one arm |
| 3 | Experimental | Drug: PEP005 Topical gelCohort 3 Two 25cm2 treatment areas; one on each arm |
| 4 | Experimental | Drug: PEP005 Topical gelCohort 4 One 25cm2 treatment area; and one 50cm2 contiguous treatment area; one on each arm |
| 5 | Experimental | Drug: PEP005 Topical gelCohort 5 One 75cm2 contiguous treatment area; on one arm |
| 6 | Experimental | Drug: PEP005 Topical gelCohort 6 Two 50cm2 contiguous treatment area; one on each arm |
| 7 | Experimental | Drug: PEP005 Topical gelCohort 7 One 25cm2 treatment area; and one 75cm2 contiguous treatment area; one on each arm |
| 8 | Experimental | Drug: PEP005 Topical gelCohort 8 One 100cm2 contiguous treatment area; on one arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be male and at least 18 years of age.
- A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions.
Key exclusion criteria (3 listed)
- Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 weeks and within 2 cm of the selected treatment area(s).
- Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system: within 4 weeks.
- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and within 2 cm of the selected treatment area(s).
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 Topical gel0.05%, two day dose | Drug | 1, 2, 3, 4, 5, 6, 7, 8 |
Primary outcome
Safety and tolerability (incidence of AEs, SAEs and skin responses)
Time frame: Screening to End of Study (Day 57)
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 14 Sep 2015.
- Derived from this study: PubMed 25584134Anderson L, Jarratt M, Schmieder G, Shumack S, Katsamas J, Welburn P. Tolerability and Pharmacokinetics of Ingenol Mebutate 0.05% Gel Applied to Treatment Areas up to 100cm(2) on the Forearm(s) of Patients with Actinic Keratosis. J Clin Aesthet Dermatol. 2014 Dec;7(12):19-29.
- Food and Drug AdministrationLink provided by the sponsor.
- Therapeutic Goods AdministrationLink 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.
George Schmieder, DO principal investigator
Park Avenue Dermatology
Stephen Shumack, MD principal investigator
St George Dermatology and Skin and Cancer Centre
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEP005 Topical gel in people with Actinic Keratosis, run by Peplin at 13 sites in 2 countries.
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 3 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 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 and tolerability (incidence of AEs, SAEs and skin responses) (time frame: Screening to End of Study (Day 57)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00659893, which also lists 1 linked publication.
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 14 Sep 2015.