Skin Safety Study to Evaluate the Sensitizing Potential in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256930
• Other study ID #: M518101-US07
• Status: Completed
• Phase: Phase 1
• First received: September 30, 2014
• Last updated: August 7, 2015
• Start date: September 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Maruho North America Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: August 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• M518101

• M518101 Vehicle

Other:
• Sodium lauryl sulfate

• Saline

Locations

Country	Name	City	State
United States	TKL research	Fair Lawn	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Maruho North America Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory skin response score	Drug application site will be evaluated for sign of inflammatory skin response (e.g. erythema, edema, papules)	21 days	Yes