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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041230032

Enrollment

Registered

2023-06-08

Start date

2023-10-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy adult

Interventions

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 uppe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Evaluation of skin disorders caused by PAL patches	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Contacts

Public ContactKatsumi Ebisawa

Nagoya University Hospital

ebisawa@med.nagoya-u.ac.jp+81-52-744-2525

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026