Cumulative Irritation Test of PAC-14028 in Healthy Volunteers
NCT ID: NCT01638117
Last Updated: 2014-01-22
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
35 participants
INTERVENTIONAL
2012-04-30
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
QUADRUPLE
Study Groups
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PAC14028-Vehicle
PAC-14028 Cream Vehicle
PAC14028-Vehicle
PAC-14028 Cream Vehicle, Daily for up to 21 days
PAC14028-0.1
PAC-14028 Cream 0.1%
PAC14028-0.1
PAC-14028 Cream, 0.1%, Daily for up to 21 days
PAC14028-0.3
PAC-14028 Cream 0.3%
PAC14028-0.3
PAC-14028 Cream, 0.3%, Daily for up to 21 days
PAC14028-1.0
PAC-14028 Cream 1%
PAC14028-1.0
PAC-14028 Cream, 1%, Daily for up to 21 days
Placebo
Saline
Saline
Saline, Daily for up to 21 days
Positive control
Sodium Lauryl Sulfate, 0.5%
Positive
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
Interventions
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PAC14028-Vehicle
PAC-14028 Cream Vehicle, Daily for up to 21 days
PAC14028-0.1
PAC-14028 Cream, 0.1%, Daily for up to 21 days
PAC14028-0.3
PAC-14028 Cream, 0.3%, Daily for up to 21 days
PAC14028-1.0
PAC-14028 Cream, 1%, Daily for up to 21 days
Saline
Saline, Daily for up to 21 days
Positive
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
* Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile). 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 readings of skin reactions.
* Who voluntarily decides study participation after receiving detailed explanation about the study and fully understanding it and who provides written consent for compliance with study requirement including proper contraception.
Exclusion Criteria
* Asthma and chronic bronchitis will be excluded.
* Inability to evaluate the skin in and around the potential patch test sites on the arm due to erythema, eschar, excoriation, tattoos, scars, unevenness in skin tones, or other skin damage or abnormality.
* A history of sensitivity to any component of any of the formulations and the Finn chamber.
* Used systemic or topical corticosteroids or other immunosuppressive medications within 1 weeks of the Day 1 visit.
* Used nonsteroidal anti-inflammatory medications within 2 weeks of the Day 1 visit.
* Received immunizations within 2 weeks of the Day 1 visit.
* Any major illness within 4 weeks of the Day 1 visit.
* Female who is pregnant, trying to become pregnant, or breast feeding
* Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study.
* Currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
20 Years
59 Years
ALL
Yes
Sponsors
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Amorepacific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Kyu-Han Kim, M.D.,Ph.D.
Role: STUDY_DIRECTOR
Seoul National University Hospital, Department of Dermatology
Locations
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Seoul National University Hospital, Department of Dermatology
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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AP-TRPV1_PI-02
Identifier Type: -
Identifier Source: org_study_id
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