Skin Safety Study to Evaluate the Sensitizing Potential in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: M518101; Drug: M518101 Vehicle; Other: Sodium lauryl sulfate; Other: Saline

• Registration Number: NCT02256930
• Lead Sponsor: Maruho North America Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-06
• Primary Completion: 2014-11
• Status Verified: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-08-07
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
M518101	M518101	M518101 will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
M518101 Vehicle	M518101 Vehicle	M518101 Vehicle will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
Sodium lauryl sulfate	Sodium lauryl sulfate	The sodium lauryl sulfate will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
Saline	Saline	The saline will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.

Primary Outcome Measures

Name	Time	Method
inflammatory skin response score	21 days	Drug application site will be evaluated for sign of inflammatory skin response (e.g. erythema, edema, papules)

Trial Locations

Locations (1)

TKL research; 🇺🇸 Fair Lawn, New Jersey, United States