HealthyPhase 1NCT00357916
Study to Determine the Sensitizing Potential of PEP005 Topical Gel in Healthy Volunteers Using a Repeat Insult Patch Test Design
A Phase 1 study testing PEP005 Topical Gel (0.01% concentration) in people with Healthy, run by Peplin at 1 site in United States.
Trial summary
To determine the sensitisation potential of PEP005 Topical Gel (0.01% concentration) on normal skin To evaluate skin irritation Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PEP005 Topical Gel (0.01% concentration)
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Oct 2006
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- are healthy males or females (to be confirmed by medical history);
- are between 18 and 65 years of age;
- have Fitzpatick skin type I, II, III, or IV
- are willing to wait 6 hours after product application to shower;
- in the case of females of childbearing potential, are using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm, or abstinence), have a negative urine pregnancy test at Screening, and submit to a pregnancy test prior to the challenge application;
- are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
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- have acceptable vital signs (ie oral body temperature, blood pressure (systolic and diastolic), and pulse rate) taken and are willing to have them taken at the end of study (EOS, within 7 days of the initial challenge evaluation);
- complete a medical screening procedure; and
- read, understand and provide signed informed consent.
Who cannot join
- have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
- have Fitzpatrick skin type V or VI;
- have excessive hair on their back;
- current drug or alcohol abuse;
- have a clinically significant illness that may influence the outcome of the study within the 4 weeks prior to and during the study;
- are not willing to refrain from using topical/systemic analgesics such as aspirin, Aleve, Motrin, Advil, or Nuprin within 72 hours prior to and during the study (occasional use of Tylenol will be permitted);
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- based on the investigator's initial examination should not participate in the study (ie, non compliance, inability to understand the study and give adequate informed consent)
- are using systemic/locally-acting medications which might counter or influence the study aim during the study and within 2 weeks prior to the beginning of the study (eg, antihistamines, or topical glucocorticosteroids);
- are using systemic/locally-acting anti-inflammitories which might counter or influence the study aim during the study and within 72 hours prior to the beginning of the study;
- are females who are pregnant, plan to become pregnant during the study, or are nursing a child;
- have a known sensitivity or allergy to constituents present in the material being evaluated; and/or
- have participated in any clinical testing of an investigational drug within 28-days or any clinical patch study within 14-days prior to or are currently participating in any clinical testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled Study to Evaluate the Sensitizing Potential of PEP005 Topical Gel (0.01% Concentration) in Healthy Volunteers Using a Repeat Insult Patch Test Design
To determine the sensitisation potential of PEP005 Topical Gel (0.01% concentration) on normal skin
To evaluate skin irritation
Read the detailed description
This is a repeat insult patch test study. On treatment days, the investigational product PEP005 Topical Gel (0.01% concentration) and vehicle control will be applied under open conditions to sites on the infrascapular region of the back 3 times weekly for 3 weeks (9 applications in total) during the induction phase. Following a rest period of approximatley 10-14 days, a single challenge application will be performed. Local tolerability will be assessed visually using an ordinal scoring system. If a cutaneous response observed in the challenge phase indicates possible sensitisation, or at the discretion of the investigator, a rechallenge will occur
- Conditions
- Healthy
- Being tested
- PEP005 Topical Gel (0.01% concentration)
- Keywords
- PEP005, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP005 Topical Gel (0.01% concentration)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the sensitization potential of PEP005 Topical Gel (0.01% concentration) on normal skin.
Secondary outcomes (1)
To evaluate skin irritation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionOct 2006
- Study completionOct 2006
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 HealthyStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Peplin
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jonathon Dosik, MD, Principal investigator, TKL Research, Inc.Peter Welburn, PhD, Study director, Peplin Operations (Sponsor)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357916
- Sponsor's protocol ID
- PEP005-005
- Status last verified
- Apr 2016
- First submitted
- 26 Jul 2006
- Last updated
- 5 Apr 2016
- Results posted
- No
Publications
Dosik JS, Damstra M, Udell C, Welburn P. Evaluation of the skin sensitization, photoirritation, and photoallergic potential of ingenol mebutate gel in healthy volunteers. J Clin Aesthet Dermatol. 2014 Apr;7(4):35-42.
PubMed 24765228
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Study to Evaluate the Sensitizing Potential of PEP005 Topical Gel (0.01% Concentration) in Healthy Volunteers Using a Repeat Insult Patch Test Design
- ClinicalTrials.gov ID
- NCT00357916
- Acronym / sponsor ID
- PEP005-005
- Conditions
- Healthy
- Keywords
- PEP005, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- PeplinIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 28 Jul 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.
To determine the sensitisation potential of PEP005 Topical Gel (0.01% concentration) on normal skin
To evaluate skin irritation
Detailed description
This is a repeat insult patch test study. On treatment days, the investigational product PEP005 Topical Gel (0.01% concentration) and vehicle control will be applied under open conditions to sites on the infrascapular region of the back 3 times weekly for 3 weeks (9 applications in total) during the induction phase. Following a rest period of approximatley 10-14 days, a single challenge application will be performed. Local tolerability will be assessed visually using an ordinal scoring system. If a cutaneous response observed in the challenge phase indicates possible sensitisation, or at the discretion of the investigator, a rechallenge will occur
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- are healthy males or females (to be confirmed by medical history);
- are between 18 and 65 years of age;
- have Fitzpatick skin type I, II, III, or IV
- are willing to wait 6 hours after product application to shower;
- in the case of females of childbearing potential, are using an acceptable form of birth control (oral/implant/injectable/transdermal contraceptives, intrauterine device, condom with spermicide, diaphragm, or abstinence), have a negative urine pregnancy test at Screening, and submit to a pregnancy test prior to the challenge application;
Key exclusion criteria (12 listed)
- have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
- have Fitzpatrick skin type V or VI;
- have excessive hair on their back;
- current drug or alcohol abuse;
- have a clinically significant illness that may influence the outcome of the study within the 4 weeks prior to and 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 |
|---|---|---|
| PEP005 Topical Gel (0.01% concentration) | Drug | – |
Primary outcome
To determine the sensitization potential of PEP005 Topical Gel (0.01% concentration) on normal skin.
1 secondary outcome
To evaluate skin irritation
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 5 Apr 2016.
- Derived from this study: PubMed 24765228Dosik JS, Damstra M, Udell C, Welburn P. Evaluation of the skin sensitization, photoirritation, and photoallergic potential of ingenol mebutate gel in healthy volunteers. J Clin Aesthet Dermatol. 2014 Apr;7(4):35-42.
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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.
Jonathon Dosik, MD principal investigator
TKL Research, Inc.
Peter Welburn, PhD study director
Peplin Operations (Sponsor)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEP005 Topical Gel (0.01% concentration) in people with Healthy, run by Peplin at 1 site 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 9 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 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
To determine the sensitization potential of PEP005 Topical Gel (0.01% concentration) on normal skin.. 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 NCT00357916, 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 5 Apr 2016.