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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01638117 |
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Date of registration:
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09/07/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cumulative Irritation Test of PAC-14028 in Healthy Volunteers
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Scientific title:
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Phase I Clinical Trial to Investigate the Cumulative Skin Irritation of PAC-14028 in Healthy Volunteers |
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Date of first enrolment:
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April 2012 |
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Target sample size:
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35 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01638117 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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Phase:
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Phase 1
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Kyu-Han Kim, M.D.,Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Hospital, Department of Dermatology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy volunteers of either sex, at least 20 years to 59 Years.
- 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:
- Atopic dermatitis/eczema, psoriasis will be excluded. Any skin disease that would in
any way confound interpretation of the study results.
- 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.
Age minimum:
20 Years
Age maximum:
59 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Other: Positive
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Drug: PAC14028-0.3
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Drug: PAC14028-1.0
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Other: PAC14028-Vehicle
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Other: Saline
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Drug: PAC14028-0.1
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Primary Outcome(s)
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Irritation Score (5-point scale, 0-4)
[Time Frame: Daily for 21 days]
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Secondary ID(s)
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AP-TRPV1_PI-02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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