Healthy
Conditions
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.
Interventions
OTHERPAC14028-Vehicle
PAC-14028 Cream Vehicle, Daily for up to 21 days
DRUGPAC14028-0.1
PAC-14028 Cream, 0.1%, Daily for up to 21 days
DRUGPAC14028-0.3
PAC-14028 Cream, 0.3%, Daily for up to 21 days
DRUGPAC14028-1.0
PAC-14028 Cream, 1%, Daily for up to 21 days
OTHERSaline
Saline, Daily for up to 21 days
OTHERPositive
Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
Sponsors
Amorepacific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 59 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Irritation Score (5-point scale, 0-4) | Daily for 21 days |
Countries
South Korea
Outcome results
None listed