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Trial record 8 of 49 for:    Sodium Lauryl Sulfate

Skin Safety Study to Evaluate the Sensitizing Potential in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02256930
Recruitment Status : Completed
First Posted : October 6, 2014
Last Update Posted : August 11, 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 sensitization potential of M518101 on normal skin under occlusive patch condition.

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

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
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
Study Start Date : September 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: M518101
M518101 will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
Drug: M518101
Placebo Comparator: M518101 Vehicle
M518101 Vehicle will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
Drug: M518101 Vehicle
Active Comparator: Sodium lauryl sulfate
The sodium lauryl sulfate will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
Other: Sodium lauryl sulfate
Sham Comparator: Saline
The saline will be applied 9 times for 21 days on the infrascapular area of the back under occlusive patch conditions.
Other: Saline



Primary Outcome Measures :
  1. inflammatory skin response score [ Time Frame: 21 days ]
    Drug application site will be evaluated for sign of inflammatory skin response (e.g. erythema, edema, papules)



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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 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

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): NCT02256930


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: NCT02256930     History of Changes
Other Study ID Numbers: M518101-US07
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015