Tinea PedisPhase 1NCT00781664
Cumulative Irritation Test
A Phase 1 study testing AN2718 and Sodium Lauryl Sulfate in people with Tinea Pedis, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- AN2718 and Sodium Lauryl Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following criteria for inclusion in the study.
- Healthy volunteers of either sex, at least 18 years of age or older.
- Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile [bilateral oophorectomy and/or total hysterectomy]). All females must submit to a urine pregnancy test and have a negative result at Day 1 and at the final study visit.
- Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions.
- Willingness to follow the study procedures and complete the study.
- Written informed consent obtained.
Who cannot join
- Any skin disease that would in any way confound interpretation of the study results. Atopic dermatitis/eczema, psoriasis will be excluded.
- Chronic asthma will be excluded.
- Pregnant or nursing mothers.
- A history of sensitivity to any component of any of the formulations.
- Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Education and Research Foundation, Inc.
Lynchburg, Virginia, 24501
About this study
Official title: 21-Day Cumulative Irritation Test
The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
Read the detailed description
Healthy, adult volunteers of either sex will be patched daily on his/her back with multiple strengths of AN2718 in 2 different topical dosage forms and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the patches will be removed and the site evaluated using a five-point scale for irritation.
- Conditions
- Tinea Pedis
- Being tested
- AN2718, Sodium Lauryl Sulfate
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN2718Other
AN2718 Cream SF Vehicle, Daily for up to 21 days
AN2718Drug
AN2718 Cream SF, 0.3%, Daily for up to 21 days
AN2718Drug
AN2718 Cream SF, 1%, Daily for up to 21 days
AN2718Other
AN2718 Gel Vehicle, Daily for up to 21 days
AN2718Drug
AN2718 Gel, 1.5%, Daily for up to 21 days
AN2718Drug
AN2718 Gel, 2.5%, Daily for up to 21 days
AN2718Drug
AN2718 Gel, 5%, Daily for up to 21 days
AN2718Drug
AN2718 Gel, 7.5%, Daily for up to 21 days
Sodium Lauryl SulfateOther
Also called SLS
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | AN2718 Cream SF Vehicle Receives: Other: AN2718 |
| B | Experimental | AN2718 Cream SF, 0.3% Receives: Drug: AN2718 |
| C | Experimental | AN2718 Cream SF, 1% Receives: Drug: AN2718 |
| D | Experimental | AN2718 Gel Vehicle Receives: Other: AN2718 |
| E | Experimental | AN2718 Gel, 1.5% Receives: Drug: AN2718 |
| F | Experimental | AN2718 Gel, 2.5% Receives: Drug: AN2718 |
| G | Experimental | AN2718 Gel, 5% Receives: Drug: AN2718 |
| H | Experimental | AN2718 Gel, 7.5% Receives: Drug: AN2718 |
| I | Active comparator | Sodium Lauryl Sulfate, 0.5% Receives: Other: Sodium Lauryl Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritation Score (5-point scale)
Measured: Daily for 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startOct 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.
- Other trials for Tinea PedisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 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
- NCT00781664
- Sponsor's protocol ID
- AN2718-TP-101
- Status last verified
- Apr 2019
- First submitted
- 28 Oct 2008
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 21-Day Cumulative Irritation Test
- ClinicalTrials.gov ID
- NCT00781664
- Acronym / sponsor ID
- AN2718-TP-101
- Conditions
- Tinea Pedis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 29 Oct 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.
The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
Detailed description
Healthy, adult volunteers of either sex will be patched daily on his/her back with multiple strengths of AN2718 in 2 different topical dosage forms and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the patches will be removed and the site evaluated using a five-point scale for irritation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: AN2718AN2718 Cream SF Vehicle |
| B | Experimental | Drug: AN2718AN2718 Cream SF, 0.3% |
| C | Experimental | Drug: AN2718AN2718 Cream SF, 1% |
| D | Experimental | Other: AN2718AN2718 Gel Vehicle |
| E | Experimental | Drug: AN2718AN2718 Gel, 1.5% |
| F | Experimental | Drug: AN2718AN2718 Gel, 2.5% |
| G | Experimental | Drug: AN2718AN2718 Gel, 5% |
| H | Experimental | Drug: AN2718AN2718 Gel, 7.5% |
| I | Active comparator | Other: Sodium Lauryl SulfateSodium Lauryl Sulfate, 0.5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects must meet all of the following criteria for inclusion in the study.
- Healthy volunteers of either sex, at least 18 years of age or older.
- Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile [bilateral oophorectomy and/or total hysterectomy]). All females must submit to a urine pregnancy test and have a negative result at Day 1 and at the final study visit.
- Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions.
- Willingness to follow the study procedures and complete the study.
Key exclusion criteria (5 listed)
- Any skin disease that would in any way confound interpretation of the study results. Atopic dermatitis/eczema, psoriasis will be excluded.
- Chronic asthma will be excluded.
- Pregnant or nursing mothers.
- A history of sensitivity to any component of any of the formulations.
- Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before 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 |
|---|---|---|
| AN2718AN2718 Cream SF Vehicle, Daily for up to 21 days | Other | A |
| AN2718AN2718 Cream SF, 0.3%, Daily for up to 21 days | Drug | B |
| AN2718AN2718 Cream SF, 1%, Daily for up to 21 days | Drug | C |
| AN2718AN2718 Gel Vehicle, Daily for up to 21 days | Other | D |
| AN2718AN2718 Gel, 1.5%, Daily for up to 21 days | Drug | E |
| AN2718AN2718 Gel, 2.5%, Daily for up to 21 days | Drug | F |
| AN2718AN2718 Gel, 5%, Daily for up to 21 days | Drug | G |
| AN2718AN2718 Gel, 7.5%, Daily for up to 21 days | Drug | H |
| Sodium Lauryl SulfateAlso: SLSSodium Lauryl Sulfate, 0.5%, Daily for up to 21 days | Other | I |
Primary outcome
Irritation Score (5-point scale)
Time frame: Daily for 21 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 16 Apr 2019.
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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 AN2718 and Sodium Lauryl Sulfate in people with Tinea Pedis, 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 6 inclusion and 5 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 16 Apr 2019. 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?
Irritation Score (5-point scale) (time frame: Daily for 21 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 16 Apr 2019.