Cumulative Irritation Test of PAC-14028 in Healthy Volunteers

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

Detailed Description
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Healthy, adult volunteers of either sex will be patched daily on his/her arm with multiple strengths of PAC-14028 cream, non-active comparator and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the Finn-chamber patches will be removed and the site evaluated using a five-point scale for irritation.

Official Title
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Phase I Clinical Trial to Investigate the Cumulative Skin Irritation of PAC-14028 in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Other: PAC14028-Vehicle
* Drug: PAC14028-0.1
* Drug: PAC14028-0.3
* Drug: PAC14028-1.0
* Other: Saline
* Other: Positive


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: PAC14028-Vehicle<br>PAC-14028 Cream Vehicle | Other: PAC14028-Vehicle<br>* PAC-14028 Cream Vehicle, Daily for up to 21 days<br>* Other names: PAC-14208 cream vehicle;|
| Experimental: PAC14028-0.1<br>PAC-14028 Cream 0.1% | Drug: PAC14028-0.1<br>* PAC-14028 Cream, 0.1%, Daily for up to 21 days<br>* Other names: PAC-14208 Cream 0.1%;|
| Experimental: PAC14028-0.3<br>PAC-14028 Cream 0.3% | Drug: PAC14028-0.3<br>* PAC-14028 Cream, 0.3%, Daily for up to 21 days<br>* Other names: PAC-14208 Cream 0.3%;|
| Experimental: PAC14028-1.0<br>PAC-14028 Cream 1% | Drug: PAC14028-1.0<br>* PAC-14028 Cream, 1%, Daily for up to 21 days<br>* Other names: PAC-14028 Cream 1.0%;|
| Placebo Comparator: Placebo<br>Saline | Other: Saline<br>* Saline, Daily for up to 21 days<br>* Other names: 0.9% Sodium chloride;|
| Active Comparator: Positive control<br>Sodium Lauryl Sulfate, 0.5% | Other: Positive<br>* Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritation Score (5-point scale, 0-4) |  | Daily for 21 days |