Cumulative Irritation Test of PAC-14028 in Healthy Volunteers

Amorepacific

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: PAC14028-Vehicle; Drug: PAC14028-1.0; Drug: PAC14028-0.3; Drug: PAC14028-0.1; Other: Saline; Other: Positive

Study type: Interventional

Funder types: Industry

Identifiers

NCT01638117

AP-TRPV1_PI-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 20 to 59 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

35 participants in 6 patient groups, including a placebo group

PAC14028-Vehicle

Placebo Comparator group

Description:

PAC-14028 Cream Vehicle

Treatment:

Other: PAC14028-Vehicle

PAC14028-0.1

Experimental group

Description:

PAC-14028 Cream 0.1%

Treatment:

Drug: PAC14028-0.1

PAC14028-0.3

Experimental group

Description:

PAC-14028 Cream 0.3%

Treatment:

Drug: PAC14028-0.3

PAC14028-1.0

Experimental group

Description:

PAC-14028 Cream 1%

Treatment:

Drug: PAC14028-1.0

Placebo

Placebo Comparator group

Description:

Saline

Treatment:

Other: Saline

Positive control

Active Comparator group

Description:

Sodium Lauryl Sulfate, 0.5%

Treatment:

Other: Positive