Cumulative Irritation Test of PAC-14028 in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: PAC14028-Vehicle; Drug: PAC14028-0.1; Drug: PAC14028-0.3; Drug: PAC14028-1.0; Other: Saline; Other: Positive

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Amorepacific Corporation
• Investigators: Study Director: Kyu-Han Kim, M.D.,Ph.D., Seoul National University Hospital, Department of Dermatology

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: July 9, 2012
• First Submitted That Met QC Criteria: July 9, 2012
• First Posted (Estimate): July 11, 2012

Study Record Updates

• Last Update Posted (Estimate): January 22, 2014
• Last Update Submitted That Met QC Criteria: January 19, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: AP-TRPV1_PI-02