Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers

NCT02227069 | Completed Phase 1

• 1 other identifier: M518101-US06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

M518101

EXPERIMENTAL

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

M518101 Vehicle

PLACEBO COMPARATOR

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

sodium lauryl sulfate

ACTIVE COMPARATOR

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

Saline

SHAM COMPARATOR

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

Interventions

M518101 DRUG

M518101

M518101 Vehicle DRUG

M518101 Vehicle

sodium lauryl sulfate OTHER

sodium lauryl sulfate

saline OTHER

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maruho North America Inc.: lead

Study Sites (1)

TKL research

Fair Lawn, New Jersey, 07410, United States

Location

MeSH Terms

Interventions

Sodium Dodecyl Sulfate; Sodium Chloride

Intervention Hierarchy (Ancestors)

Dodecanol; Fatty Alcohols; Alcohols; Organic Chemicals; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Lipids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 27, 2014
• Study Start: September 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: March 1, 2015
• Last Updated: March 30, 2015

Record last verified: 2015-03

Locations

US (1)