Safety study of Plasma-activated Lactate Ringer's Solution (PAL) for application on human normal skin

JRCT ID: jRCTs041230032

Registered date:08/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: healthy adult
• Date of first enrollment: 24/10/2023
• Target sample size: 18
• Study type: Interventional
• Intervention(s): Patch testing of 3 samples (filter paper only, filter paper dropped 0.02mL of Lactate Ringer's Solution and filter paper dropped 0.02mL of PAL) using fin chamber for 48 hours on the participant's upper arm.

Outcome(s)

• Primary Outcome: Evaluation of skin disorders caused by PAL patches

Secondary Outcome

Evaluation of changes in blood test and urinalysis data* before and after the PAL patch test
*;
Blood test: White blood cell count, Red blood cell count, Hemoglobin, Hematocrit, Blood platelet count, Total protein, Albumin, Glucose, Urea nitrogen, Creatinine, Sodium, Potassium, Chlorine, AST(GOT), ALT(GPT), LDH, ALP, gamma-GTP, Total bilirubin, Zinc, CRP, Oxidative stress profile (CoQ10 oxidation rate, LPO, Iron, Copper, Cholesterol, Triglyceride, STAS, Uric acid, Vitamin C, Folic acid, Vitamin B12, Lutein + zeaxanthin, beta-cryptoxanthin, Lycopene, alpha-carotene, beta-carotene, Vitamin A, alpha-tocopherol, delta-tocopherol, beta_gamma-tocopherol, alpha-tocopherol/cholesterol, ubiquinol)
Urinalysis: pH, Protein qualitative, Glucose qualitative, Urobilinogen, Bilirubin, Ketone body, Occult blood qualitative, Specific gravity, Oxidative stress profile (8-OHdG generation speed, Isoprostane generation speed)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Ages 18 and over
2. Subjects who are healthy and are not suffered from skin disease
3. Subjects who can be prohibited from taking medicines from one week before the start of the study until the end of the study
4. Subjects who received a sufficient explanation of the purpose and contents of this study, voluntarily apply for participation after fully understanding, agreeing in writing

Exclude criteria

1. Subjects who have used drugs, patches, and external preparations within one week
2. Subjects who cannot keep the affected area rest
3. Subjects with cognitive problems
4. Subjects with decision-making problems
5. Subjects in the department to which the principal investigator and co-investigator belong
6. In addition, subjects judged unsuitable for doctors to carry out this study safely

Related Information

• Primary Sponsor: Ebisawa Katsumi
• Source(s) of Monetary Support: Fuji Corporation