Cumulative Irritation Test of PAC-14028 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Other: Saline; Other: PAC14028-Vehicle; Drug: PAC14028-0.1; Drug: PAC14028-0.3; Drug: PAC14028-1.0; Other: Positive

• Registration Number: NCT01638117
• Lead Sponsor: Amorepacific Corporation

Brief Summary

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

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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2012-07-09
• Study First Posted: 2012-07-11
• Primary Completion: 2012-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-19
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline	Saline
PAC14028-Vehicle	PAC14028-Vehicle	PAC-14028 Cream Vehicle
PAC14028-0.1	PAC14028-0.1	PAC-14028 Cream 0.1%
PAC14028-0.3	PAC14028-0.3	PAC-14028 Cream 0.3%
PAC14028-1.0	PAC14028-1.0	PAC-14028 Cream 1%
Positive control	Positive	Sodium Lauryl Sulfate, 0.5%

Primary Outcome Measures

Name	Time	Method
Irritation Score (5-point scale, 0-4)	Daily for 21 days

Trial Locations

Locations (1)

Seoul National University Hospital, Department of Dermatology; 🇰🇷 Seoul, Korea, Republic of