Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers

Maruho

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: sodium lauryl sulfate; Drug: M518101; Drug: M518101 Vehicle; Other: saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT02227069

M518101-US06

Details and patient eligibility

About

This is a single center, randomized, controlled, within-subject comparison, multiple dose study to determine the irritation potential of M518101 on normal skin under occlusive patch condition.

The study drug will be applied for 21 days under occlusive patch condition. The irritation potential of M518101 will be compared with positive, negative control and M518101 vehicle. The study duration is 21days and there will be at least 23 visits to study center including screening visit.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Health male or female subjects age 18 years or older
• Signed and dated Informed Consent Form obtained prior to any study-related activities
• Subjects are free of any systemic or dermatologic disorder
• For Female, females of non-childbearing potential or who agree to use a highly effective method of birth control during the study and have a negative urine pregnancy test.
• Subjects must be able to communicate with the investigator and understand and comply with the requirements of the study and visit schedule

Exclusion criteria

• Have any visible skin disease at the application site which will interfere with the evaluation of the test site reaction
• Have damaged skin in or around the test sites
• Have a history of sensitivity to adhesive tape
• Have a known sensitivity to constituents present in the material being evaluated
• Have a history of, or are currently being treated for skin cancer
• have used any study drug and/or participate in any clinical study within 60 days prior to Randomization
• to engage in any type of strenuous exercise (swimming, running, etc.) or who intended to use hot tubs or saunas during the study
• Are pregnant, breastfeeding, or of childbearing potential and who wish to become pregnant during the study
• Are deemed to be ineligible by the investigator

Trial design

30 participants in 4 patient groups, including a placebo group

M518101

Experimental group

Description:

M518101 is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks

Treatment:

Drug: M518101

M518101 Vehicle

Placebo Comparator group

Description:

M518101 vehicle is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks

Treatment:

Drug: M518101 Vehicle

sodium lauryl sulfate

Active Comparator group

Description:

A solution of 0.2% sodium lauryl sulfate is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a positive control.

Treatment:

Other: sodium lauryl sulfate

Saline

Sham Comparator group

Description:

A solution of 0.9% saline is applied topically under occlusive patch conditions to the infrascapular area of the back once daily for 21 days over 3 weeks, will serve as a negative control.

Treatment:

Other: saline