Clincosm LogoSign in Get a demo

4-Day Primary Irritation Patch Test of MIS Solution

Sponsor
Next Science TM (Industry)
Overall Status
Completed
CT.gov ID
NCT06119750
Collaborator
TKL Research, Inc. (Industry)
33
Enrollment
3
Arms
29
Actual Duration (Days)

Study Details

Study Description

Brief Summary

This is a 7 day primary irritation patch test. This study investigates the irritation potential of Next Science MIS Wound Irrigation Solution under standardized conditions compared with an inert control (normal saline) and a known irritant, 20% sodium dodecyl sulfate (also known as sodium lauryl sulfate [SLS]) solution in deionized water [DI] water) on intact skin of healthy human subjects.

Condition or Disease Intervention/Treatment Phase
  • Device: NS Solution
  • Other: Normal Saline
  • Other: SLS
 N/A

Detailed Description

In accordance with ISO 10993-10:2010(E), study products will be delivered via dermal patch at 15 and 30 minutes (min) and up to 1-hour (h), 2-h, 3-h, 4-h and then, pending results, 24-h (evaluated up to at least 48-h) continuous exposure. Response rate will be evaluated immediately after application then 1 h, 2 h, 24 h, 48 h, and then 72 h post-exposure.

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Subjects act as their own control. They each receive all three study treatment via patch application.Subjects act as their own control. They each receive all three study treatment via patch application.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
4-Day Primary Irritation Patch Test of MIS Solution
Actual Study Start Date :
Jul 6, 2020
Actual Primary Completion Date :
Jul 16, 2020
Actual Study Completion Date :
Aug 4, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: MIS Solution

device under investigation

Device: NS Solution
This will be administered via skin patch.
Other Names:
  • Antimicrobial Solution

    		•
    Placebo Comparator: Saline

    0.9%

    Other: Normal Saline
    This will be administered via skin patch.
    Other Names:
  • Negative Control

    		•
    Active Comparator: Sodium Lauryl Sulfate

    20%

    Other: SLS
    This will be administered via skin patch.
    Other Names:
  • Positive Control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To evaluate the effects of wound solution on healthy volunteers when applied to the skin. [7 days]

      Response Grade of Irritation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Individuals eligible for inclusion in the study were those who:

    1. Were male or female, 18 - 75 years of age, in general good health (confirmed by medical history);

    2. If females of childbearing potential, were using an acceptable form of birth control (i.e., oral contraceptive, intra-uterine device [IUD], diaphragm, condom, abstinence, bilateral tubal ligation, or are in a monogamous relationship with a partner who had a vasectomy);

    3. In the case of females of childbearing potential, had a negative urine pregnancy test (UPT) at Screening (a woman was considered to be of non-childbearing potential if she was postmenopausal for at least 12 months or was surgically sterile [hysterectomy, bilateral oophorectomy]);

    4. Agreed not to use systemic/topical corticosteroids within 3 weeks prior to and/or during the study, or systemic/topical antihistamines 72 hours prior to and during the study;

    5. Agreed not to use systemic/topical analgesics such as aspirin (81 mg daily aspirin were allowed at the discretion of the Investigator), Aleve, Motrin, Advil, or Nuprin for 72 hours prior to and during the study (occasional use of acetaminophen was permitted);

    6. Were free of any systemic or dermatologic disorder which, in the opinion of the investigative personnel, interfered with the study results or increased the risk of adverse events (AEs);

    7. Were of any skin type or race providing the skin pigmentation allowed for discernment of erythema;

    8. Completed a medical screening procedure; and

    9. Read, understood, and signed an informed consent agreement

    Exclusion Criteria:
    • Had any visible skin disease at the study site which, in the opinion of the investigative personnel, would have interfered with the evaluation; 2. Were receiving systematic or topical drugs or medication which, in the opinion of the investigative personnel, would have interfered with the study results; 3. Had psoriasis and/or active atopic dermatitis/eczema; and/or 4. Had a known sensitivity to cosmetics, skin care products, or topical drugs as related to the material being evaluated. 5. Had a history of allergies or sensitivity to study material being tested. 6. Were pregnant women. 7. Were women who were breast-feeding.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Next Science TM
    • TKL Research, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Next Science TM
    ClinicalTrials.gov Identifier:
    NCT06119750
    Other Study ID Numbers:
    • CSP-020
    • DS210120
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Nov 7, 2023