4-Day Primary Irritation Patch Test of MIS Solution

Not Applicable

Completed

• Conditions: Healthy; Reactions Adverse; Irritation/Irritant
• Interventions: Device: NS Solution; Other: Normal Saline; Other: SLS

• Registration Number: NCT06119750
• Lead Sponsor: Next Science TM

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.

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 Timeline

• Study Start: 2020-07-06
• Primary Completion: 2020-07-16
• Study Completion: 2020-08-04
• Study First Submitted: 2023-04-17
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-01
• Last Update Submitted: 2023-11-01
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIS Solution	NS Solution	device under investigation
Saline	Normal Saline	0.9%
Sodium Lauryl Sulfate	SLS	20%

Primary Outcome Measures

Name	Time	Method
To evaluate the effects of wound solution on healthy volunteers when applied to the skin.	7 days	Response Grade of Irritation