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Cumulative Irritation Test

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
The Education and Research Foundation, Inc.
Lynchburg, Virginia, 24501 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Onychomycosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00680095
Pfizer
Completed
Cumulative Irritation Test

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Cumulative Irritation Test
21-day Cumulative Irritation Test
The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
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.
Interventional
Phase 1
Masking: None (Open Label)
Primary Purpose: Other
Onychomycosis
  • Drug: AN2690
    AN2690 Solution, 2.5%, Daily for up to 21 days
  • Drug: AN2690
    AN2690 Solution, 7.5%, Daily for up to 21 days
  • Drug: AN2690
    AN2690 Solution, 5.0%, Daily for up to 21 days
  • Other: AN2690 Solution, Vehicle
    AN2690 Solution, Vehicle, Daily for up to 21 days
  • Other: Sodium Lauryl Sulfate, 0.5%
    Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
  • Experimental: A
    AN2690 Solution, 2.5%
    Intervention: Drug: AN2690
  • Experimental: B
    AN2690 Solution, 7.5%
    Intervention: Drug: AN2690
  • Experimental: C
    AN2690 Solution, 5.0%
    Intervention: Drug: AN2690
  • Active Comparator: D
    AN2690 Solution, Vehicle
    Intervention: Other: AN2690 Solution, Vehicle
  • Active Comparator: E
    Sodium Lauryl Sulfate, 0.5%
    Intervention: Other: Sodium Lauryl Sulfate, 0.5%
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
February 28, 2007
February 28, 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00680095
AN2690-ONYC-101
C3371011 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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