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Completed

NCT Number: NCT02227069

Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

TKL research

Fair Lawn, New Jersey, 07410, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

M518101

Drug

M518101 Vehicle

Drug

sodium lauryl sulfate

Other

Saline

Other

Primary outcomes

  1. Inflammatory skin responses

    Time frame: 21 Days

    Drug application sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects.

Sponsors and collaborators

Lead sponsor

Maruho North America Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Aug 27, 2014
Registry last updated
Mar 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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