4-Day Primary Irritation Patch Test of MIS Solution

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Irritation/Irritant; Reactions Adverse
• Intervention / Treatment: Device: NS Solution; Other: Normal Saline; Other: SLS

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effects of wound solution on healthy volunteers when applied to the skin.	Response Grade of Irritation	7 days

Collaborators and Investigators

• Sponsor: Next Science TM
• Collaborators: TKL Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): July 16, 2020
• Study Completion (Actual): August 4, 2020

Study Registration Dates

• First Submitted: April 17, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: CSP-020; DS210120 (Other Identifier: TKL Research, Inc)

Drug and device information, study documents

• 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