Status:
COMPLETED
4-Day Primary Irritation Patch Test of MIS Solution
Lead Sponsor:
Next Science TM
Collaborating Sponsors:
TKL Research, Inc.
Conditions:
Healthy
Irritation/Irritant
Eligibility:
All Genders
18-75 years
Phase:
NA
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 contr...
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 ...
Eligibility Criteria
Inclusion
- Individuals eligible for inclusion in the study were those who:
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
July 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2020
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06119750
Start Date
July 6 2020
End Date
August 4 2020
Last Update
November 7 2023
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