Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2008-10-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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A
AN2718 Cream SF Vehicle
AN2718
AN2718 Cream SF Vehicle, Daily for up to 21 days
B
AN2718 Cream SF, 0.3%
AN2718
AN2718 Cream SF, 0.3%, Daily for up to 21 days
C
AN2718 Cream SF, 1%
AN2718
AN2718 Cream SF, 1%, Daily for up to 21 days
D
AN2718 Gel Vehicle
AN2718
AN2718 Gel Vehicle, Daily for up to 21 days
E
AN2718 Gel, 1.5%
AN2718
AN2718 Gel, 1.5%, Daily for up to 21 days
F
AN2718 Gel, 2.5%
AN2718
AN2718 Gel, 2.5%, Daily for up to 21 days
G
AN2718 Gel, 5%
AN2718
AN2718 Gel, 5%, Daily for up to 21 days
H
AN2718 Gel, 7.5%
AN2718
AN2718 Gel, 7.5%, Daily for up to 21 days
I
Sodium Lauryl Sulfate, 0.5%
Sodium Lauryl Sulfate
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
Interventions
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AN2718
AN2718 Cream SF Vehicle, Daily for up to 21 days
AN2718
AN2718 Cream SF, 0.3%, Daily for up to 21 days
AN2718
AN2718 Cream SF, 1%, Daily for up to 21 days
AN2718
AN2718 Gel Vehicle, Daily for up to 21 days
AN2718
AN2718 Gel, 1.5%, Daily for up to 21 days
AN2718
AN2718 Gel, 2.5%, Daily for up to 21 days
AN2718
AN2718 Gel, 5%, Daily for up to 21 days
AN2718
AN2718 Gel, 7.5%, Daily for up to 21 days
Sodium Lauryl Sulfate
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Healthy volunteers of either sex, at least 18 years of age or older.
2. 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.
3. Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions.
4. Willingness to follow the study procedures and complete the study.
5. Written informed consent obtained.
Exclusion Criteria
2. Chronic asthma will be excluded.
3. Pregnant or nursing mothers.
4. A history of sensitivity to any component of any of the formulations.
5. Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study.
18 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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The Education and Research Foundation, Inc.
Lynchburg, Virginia, United States
Countries
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Other Identifiers
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AN2718-TP-101
Identifier Type: -
Identifier Source: org_study_id
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