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Trial record 9 of 49 for:    Sodium Lauryl Sulfate

Skin Safety Study to Evaluate the Irritation Potential in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02227069
Recruitment Status : Completed
First Posted : August 27, 2014
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
Maruho North America Inc.

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.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: M518101 Drug: M518101 Vehicle Other: sodium lauryl sulfate Other: saline Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Official 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
Study Start Date : September 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : March 2015

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



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227069


Locations
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United States, New Jersey
TKL research
Fair Lawn, New Jersey, United States, 07410
Sponsors and Collaborators
Maruho North America Inc.

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Responsible Party: Maruho North America Inc.
ClinicalTrials.gov Identifier: NCT02227069     History of Changes
Other Study ID Numbers: M518101-US06
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015