Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers

A Phase 1, 21-Day, Randomized, Evaluator Blinded, Controlled Study to Evaluate the Irritation Potential of M518101 in Healthy Volunteers, Using a Cumulative Irritant Patch Test Design

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 30
• 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 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

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 is applied topically under occlusive patch conditions to the infrascapular area of the back, once daily for 21 consecutive days over 3 weeks	Drug: M518101
Placebo Comparator: M518101 Vehicle; 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	Drug: M518101 Vehicle
Active Comparator: sodium lauryl sulfate; 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.	Other: sodium lauryl sulfate
Sham Comparator: Saline; 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.	Other: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory skin responses	Drug application sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects.	21 Days

Collaborators and Investigators

• Sponsor: Maruho North America Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 25, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Estimate): March 30, 2015
• Last Update Submitted That Met QC Criteria: March 27, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: M518101-US06