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4-Day Primary Irritation Patch Test of MIS Solution

N

Next Science

Status

Completed

Conditions

Healthy
Reactions Adverse
Irritation/Irritant

Treatments

Other: SLS
Other: Normal Saline
Device: NS Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT06119750
DS210120 (Other Identifier)
CSP-020

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

33 participants in 3 patient groups, including a placebo group

MIS Solution
Experimental group
Description:
device under investigation
Treatment:
Device: NS Solution
Saline
Placebo Comparator group
Description:
0.9%
Treatment:
Other: Normal Saline
Sodium Lauryl Sulfate
Active Comparator group
Description:
20%
Treatment:
Other: SLS

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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