Stratum corneum sampling study for validation of analytical method for drug concentration in human stratum corneum

JRCT ID: jRCT1030240253

Registered date:06/08/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Pain relief and anti-inflammation
• Date of first enrollment: 29/07/2024
• Target sample size: 6
• Study type: Observational

Outcome(s)

Primary Outcome

Stratum corneum sampling
TEWL measurement value

• Secondary Outcome: none

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 40age old
• Gender: Male

Include criteria

(1) Age: 20 to 40 years old (at the time of obtaining consent)
(2) Persons whose BMI [Body Mass Index: weight (kg) / height (mm)2] is 18.5 kg/m2 or more and less than 25 kg/m2 (numbers are not rounded).

• Exclude criteria: Persons with have skin wounds at the site of stratum corneum collection, and those who have skin symptoms such as eczema, contact dermatitis, psoriasis, seborrheic dermatitis, dyschromatosis, and excessive sunburn at the site of stratum corneum collection.

Related Information

• Primary Sponsor: Takazawa Kenji