Skin Safety Study to Evaluate the Sensitizing Potential in Healthy Volunteers

Maruho

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: M518101 Vehicle; Drug: M518101; Other: Saline; Other: Sodium lauryl sulfate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02256930

M518101-US07

Details and patient eligibility

About

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

Full description

During the Induction Phase of the study, the study drugs and controls will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.

Following induction, subjects will have a 10 to 14-day Rest phase, after which they will enter the challenge Phase, which consists of one 48-hour patch application (occlusive) to a naïve site on the opposite side of the back.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Health male or female subjects are 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 requirement 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
• 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

240 participants in 4 patient groups, including a placebo group

M518101

Experimental group

Description:

M518101 will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.

Treatment:

Drug: M518101

M518101 Vehicle

Placebo Comparator group

Description:

M518101 Vehicle will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.

Treatment:

Drug: M518101 Vehicle

Sodium lauryl sulfate

Active Comparator group

Description:

The sodium lauryl sulfate will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.

Treatment:

Other: Sodium lauryl sulfate

Saline

Sham Comparator group

Description:

The saline will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.

Treatment:

Other: Saline