4-Day Primary Irritation Patch Test of MIS Solution

NCT06119750 | Completed FDA Device

• 2 other identifiers: CSP-020DS210120
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy; Irritation/Irritant; Reactions Adverse

Outcome Measures

Primary Outcomes (1)

• To evaluate the effects of wound solution on healthy volunteers when applied to the skin.

  Response Grade of Irritation

  7 days

Study Arms (3)

MIS Solution

EXPERIMENTAL

device under investigation

Device: NS Solution

Saline

PLACEBO COMPARATOR

0.9%

Other: Normal Saline

Sodium Lauryl Sulfate

ACTIVE COMPARATOR

20%

Other: SLS

Interventions

NS Solution DEVICE

This will be administered via skin patch.

Also known as: Antimicrobial Solution

MIS Solution

Normal Saline OTHER

This will be administered via skin patch.

Also known as: Negative Control

Saline

SLS OTHER

This will be administered via skin patch.

Also known as: Positive Control

Sodium Lauryl Sulfate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: at least 1/3 males and 1/3 females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Were male or female, 18 - 75 years of age, in general good health (confirmed by medical history);
• 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);
• 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 \[hysterectomy, bilateral oophorectomy\]);
• 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;
• 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);
• 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);
• Were of any skin type or race providing the skin pigmentation allowed for discernment of erythema;
• Completed a medical screening procedure; and
• Read, understood, and signed an informed consent agreement

You may not qualify if:

• 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.

Sponsors & Collaborators

• Next Science TM: lead
• TKL Research, Inc.: collaborator

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects act as their own control. They each receive all three study treatment via patch application.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: November 7, 2023
• Study Start: July 6, 2020
• Primary Completion: July 16, 2020
• Study Completion: August 4, 2020
• Last Updated: November 7, 2023

Record last verified: 2023-11