Skin Safety Study to Evaluate the Sensitizing Potential in Healthy Volunteers

A Phase 1, Randomized, Evaluator Blinded, Controlled Study to Evaluate the Sensitizing Potential of M518101 in Healthy Volunteers Using a Repeat Insult Patch Test Design

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Saline; Drug: M518101; Drug: M518101 Vehicle; Other: Sodium lauryl sulfate

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fair Lawn, New Jersey, United States, 07410
      • TKL Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M518101; M518101 will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.	Drug: M518101
Placebo Comparator: M518101 Vehicle; M518101 Vehicle will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.	Drug: M518101 Vehicle
Active Comparator: 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.	Other: Sodium lauryl sulfate
Sham Comparator: Saline; The saline will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.	Other: Saline

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Maruho North America Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: September 30, 2014
• First Submitted That Met QC Criteria: October 1, 2014
• First Posted (Estimate): October 6, 2014

Study Record Updates

• Last Update Posted (Estimate): August 11, 2015
• Last Update Submitted That Met QC Criteria: August 7, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: M518101-US07