OnychomycosisPhase 1NCT00680095
Cumulative Irritation Test
A Phase 1 study testing AN2690 and Sodium Lauryl Sulfate, 0.5% in people with Onychomycosis, 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
- Onychomycosis
- What is being tested?
- AN2690 and Sodium Lauryl Sulfate, 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2007to 19 Feb 2007
- 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, volunteers of either sex, at least 18 years of age or older
- Females of childbearing potential submitted to a urine pregnancy test and had negative results at Day 1 and at the final visit and also was using an effective method of birth control (e.g. abstinence, implants, injectables, oral contraceptives, intrauterine contraceptive devices or double barrier) or agreed to use an effective method of birth control prior to becoming sexual active
- Subjects were of any skin type or race providing their degree of pigmentation did not interfere with making readings of skin reactions
- Subjects were willing to follow the study procedures and complete the study
- Written informed consent was obtained
Who cannot join
- Subject with any skin disease that would have in any way confounded interpretation of the study results. Atopic dermatitis/eczema, psoriasis or chronic asthma were excluded
- Subject was pregnant or nursing
- Subject had 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 on his/her back with AN2690 Solution 2.5%, AN2690 Solution 5%, AN2690 Solution 7.5%, AN2690 Solution Vehicle and Sodium Laurel Sulfate 0.5% over the course of 21 consecutive days. After 24 hours, the patches are to be removed and the site evaluated using a five-point scale for irritation.
- Conditions
- Onychomycosis
- Being tested
- AN2690, AN2690 Solution, Vehicle, Sodium Lauryl Sulfate, 0.5%
- Keywords
- Onychomycosis, Fungal Nail
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AN2690Drug
AN2690 Solution, 2.5%, Daily for up to 21 days
AN2690Drug
AN2690 Solution, 7.5%, Daily for up to 21 days
AN2690Drug
AN2690 Solution, 5.0%, Daily for up to 21 days
AN2690 Solution, VehicleOther
AN2690 Solution, Vehicle, Daily for up to 21 days
Sodium Lauryl Sulfate, 0.5%Other
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | AN2690 Solution, 2.5% Receives: Drug: AN2690 |
| B | Experimental | AN2690 Solution, 7.5% Receives: Drug: AN2690 |
| C | Experimental | AN2690 Solution, 5.0% Receives: Drug: AN2690 |
| D | Active comparator | AN2690 Solution, Vehicle Receives: Other: AN2690 Solution, Vehicle |
| E | Active comparator | Sodium Lauryl Sulfate, 0.5% Receives: Other: Sodium Lauryl Sulfate, 0.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe irritation (Grade 3 or 4) observed at any site
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 posted19 May 2008 (estimated)
- Study start22 Jan 2007
- Primary completion19 Feb 2007
- Study completion19 Feb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OnychomycosisStudies 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
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT00680095
- Sponsor's protocol ID
- AN2690-ONYC-101
- Other IDs
- C3371011
- Status last verified
- Apr 2019
- First submitted
- 15 May 2008
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 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
- NCT00680095
- Acronym / sponsor ID
- AN2690-ONYC-101
- Conditions
- Onychomycosis
- Keywords
- Onychomycosis, Fungal Nail
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 22 Jan 2007 (actual)
- Primary completion
- 19 Feb 2007 (actual)
- Study completion
- 19 Feb 2007 (actual)
- First posted
- 19 May 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 on his/her back with AN2690 Solution 2.5%, AN2690 Solution 5%, AN2690 Solution 7.5%, AN2690 Solution Vehicle and Sodium Laurel Sulfate 0.5% over the course of 21 consecutive days. After 24 hours, the patches are to be removed and the site evaluated using a five-point scale for irritation.
Study design
- Primary purpose
- Other
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: AN2690AN2690 Solution, 2.5% |
| B | Experimental | Drug: AN2690AN2690 Solution, 7.5% |
| C | Experimental | Drug: AN2690AN2690 Solution, 5.0% |
| D | Active comparator | Other: AN2690 Solution, VehicleAN2690 Solution, Vehicle |
| E | Active comparator | Other: Sodium Lauryl Sulfate, 0.5%Sodium 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 (5 listed)
- Healthy, volunteers of either sex, at least 18 years of age or older
- Females of childbearing potential submitted to a urine pregnancy test and had negative results at Day 1 and at the final visit and also was using an effective method of birth control (e.g. abstinence, implants, injectables, oral contraceptives, intrauterine contraceptive devices or double barrier) or agreed to use an effective method of birth control prior to becoming sexual active
- Subjects were of any skin type or race providing their degree of pigmentation did not interfere with making readings of skin reactions
- Subjects were willing to follow the study procedures and complete the study
- Written informed consent was obtained
Key exclusion criteria (4 listed)
- Subject with any skin disease that would have in any way confounded interpretation of the study results. Atopic dermatitis/eczema, psoriasis or chronic asthma were excluded
- Subject was pregnant or nursing
- Subject had 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 |
|---|---|---|
| AN2690AN2690 Solution, 2.5%, Daily for up to 21 days | Drug | A |
| AN2690AN2690 Solution, 7.5%, Daily for up to 21 days | Drug | B |
| AN2690AN2690 Solution, 5.0%, Daily for up to 21 days | Drug | C |
| AN2690 Solution, VehicleAN2690 Solution, Vehicle, Daily for up to 21 days | Other | D |
| Sodium Lauryl Sulfate, 0.5%Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days | Other | E |
Primary outcome
Severe irritation (Grade 3 or 4) observed at any site
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 9 Apr 2019.
Related trials for Onychomycosis
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
Onychomycosis
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail
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 AN2690 and Sodium Lauryl Sulfate, 0.5% in people with Onychomycosis, 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 5 inclusion and 4 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 9 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?
Severe irritation (Grade 3 or 4) observed at any site (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 9 Apr 2019.