PainPhase 1NCT01787448
RIPT of Ibuprofen Topical Gel
A Phase 1 study testing Sodium lauryl sulfate 0.1% and Sodium chloride solution 0.9% (saline) in people with Pain, run by Pfizer at 1 site in United States.
Trial summary
This study is being conducted to determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause sensitization after repeated topical application to healthy skin of human subjects under controlled conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Sodium lauryl sulfate 0.1% and Sodium chloride solution 0.9% (saline)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Feb 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects 18 years of age or older, female subjects of childbearing potential and males are using an acceptable form of birth control, subjects are free of any systemic or dermatologic disorder
Who cannot join
- Have any visible skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, not willing to stop use of sunscreens, creams, or similar products on the back during the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
Carlstadt, New Jersey, 07652
About this study
Official title: Repeat-insult Patch Test (Ript) of Ibuprofen 5% Topical Gel in Human Volunteers
This study is being conducted to determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause sensitization after repeated topical application to healthy skin of human subjects under controlled conditions.
- Conditions
- Pain
- Being tested
- Topical gel vehicle, Sodium lauryl sulfate 0.1%, Sodium chloride solution 0.9% (saline)
- Keywords
- repeat insult patch test
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical gel vehicleDrug
0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
Topical gel vehicleDrug
0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
Sodium lauryl sulfate 0.1%Drug
0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
Sodium chloride solution 0.9% (saline)Drug
0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen 5% topical gel | Experimental | Not described Receives: Drug: Topical gel vehicle |
| Topical gel vehicle | Experimental | Not described Receives: Drug: Topical gel vehicle |
| Sodium lauryl sulfate 0.1% | Active comparator | Not described Receives: Drug: Sodium lauryl sulfate 0.1% |
| Sodium chloride solution 0.9% (saline) | Sham comparator | Not described Receives: Drug: Sodium chloride solution 0.9% (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermal sensitization potential
Measured: 24-72 hours after last patch removal
Secondary outcomes (2)
Cumulative Irritancy
Measured: 48-72 hours after each patch application
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: During study through 28 days after last product application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787448
- Sponsor's protocol ID
- B3491007
- Status last verified
- Feb 2013
- First submitted
- 5 Dec 2012
- Last updated
- 28 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeat-insult Patch Test (Ript) of Ibuprofen 5% Topical Gel in Human Volunteers
- ClinicalTrials.gov ID
- NCT01787448
- Acronym / sponsor ID
- B3491007
- Conditions
- Pain
- Keywords
- repeat insult patch test
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 8 Feb 2013 (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.
This study is being conducted to determine the potential of Ibuprofen 5% Topical Gel and its vehicle gel to cause sensitization after repeated topical application to healthy skin of human subjects under controlled conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen 5% topical gel | Experimental | Drug: Topical gel vehicle |
| Topical gel vehicle | Experimental | Drug: Topical gel vehicle |
| Sodium lauryl sulfate 0.1% | Active comparator | Drug: Sodium lauryl sulfate 0.1% |
| Sodium chloride solution 0.9% (saline) | Sham comparator | Drug: Sodium chloride solution 0.9% (saline) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male or female subjects 18 years of age or older, female subjects of childbearing potential and males are using an acceptable form of birth control, subjects are free of any systemic or dermatologic disorder
Key exclusion criteria (1 listed)
- Have any visible skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, not willing to stop use of sunscreens, creams, or similar products on the back 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 |
|---|---|---|
| Topical gel vehicle0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application | Drug | Ibuprofen 5% topical gel |
| Topical gel vehicle0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application | Drug | Topical gel vehicle |
| Sodium lauryl sulfate 0.1%0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application | Drug | Sodium lauryl sulfate 0.1% |
| Sodium chloride solution 0.9% (saline)0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application | Drug | Sodium chloride solution 0.9% (saline) |
Primary outcome
Dermal sensitization potential
Time frame: 24-72 hours after last patch removal
2 secondary outcomes
Cumulative Irritancy
Time frame: 48-72 hours after each patch application
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: During study through 28 days after last product application
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 Feb 2013.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
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 Sodium lauryl sulfate 0.1% and Sodium chloride solution 0.9% (saline) in people with Pain, run by Pfizer 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 1 inclusion and 1 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 Feb 2013. 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. 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 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?
Dermal sensitization potential (time frame: 24-72 hours after last patch removal). 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 Feb 2013.