Expired Study
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Lynchburg, Virginia 24501


Purpose:

The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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


Study is Available At:


Original ID:

AN2690-ONYC-101


NCT ID:

NCT00680095


Secondary ID:

C3371011


Study Acronym:


Brief Title:

Cumulative Irritation Test


Official Title:

21-day Cumulative Irritation Test


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

5


Number of Groups:

0


Total Enrollment:

37


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:January 22, 2007
Completion Date:February 19, 2007
Completion Type:Actual
Primary Completion Date:February 19, 2007
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 5, 2019
First Received Date:May 15, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Severe irritation (Grade 3 or 4) observed at any site
Time Frame:Daily for 21 days
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:AN2690
Description:AN2690 Solution, 2.5%, Daily for up to 21 days
Arm Name:A
Intervention Type:Drug
Name:AN2690
Description:AN2690 Solution, 7.5%, Daily for up to 21 days
Arm Name:B
Intervention Type:Drug
Name:AN2690
Description:AN2690 Solution, 5.0%, Daily for up to 21 days
Arm Name:C
Intervention Type:Other
Name:AN2690 Solution, Vehicle
Description:AN2690 Solution, Vehicle, Daily for up to 21 days
Arm Name:D
Intervention Type:Other
Name:Sodium Lauryl Sulfate, 0.5%
Description:Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
Arm Name:E

Study Arms

Study Arm Type:Active Comparator
Arm Name:E
Description:Sodium Lauryl Sulfate, 0.5%
Study Arm Type:Active Comparator
Arm Name:D
Description:AN2690 Solution, Vehicle
Study Arm Type:Experimental
Arm Name:C
Description:AN2690 Solution, 5.0%
Study Arm Type:Experimental
Arm Name:B
Description:AN2690 Solution, 7.5%
Study Arm Type:Experimental
Arm Name:A
Description:AN2690 Solution, 2.5%

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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