Skip to content

In-Use Safety Evaluation to Determine the Dermal Irritation Potential and Consumer Perception of a Test Material

In-Use Safety Evaluation to Determine the Dermal Irritation Potential and Consumer Perception of a Test Material - In-Use Safety Evaluation to Determine the Dermal Irritation Potential and Consumer Perception of a Test Material

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047963
Enrollment
35
Registered
2022-06-07
Start date
2022-05-20
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

sensitive skin

Interventions

Sponsors

Lion Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a) Subject is male or female between 21 to 59 years of age (age and sex to be captured in the demographics); b) A subject exhibits no edema at the Baseline visit; c) Subject agrees not to introduce any new cosmetic or toiletry products during the study; d) Subject agrees not to use their regular body moisturizer or lotion for the duration of the study; e) Subject is a regular user of any type of body moisturizer (name and brand to be captured in demographics); f) Subject identifies as having self-perceived eczema prone skin; g) Subject has at least one of three conditions: significantly dry skin (2: mild to 3: moderate dry skin as determined by a board certified dermatologist), history of eczema, or history of atopic diathesis (skin condition to be captured in the demographics); h) Subject agrees to refrain from tanning and swimming for the duration of the study; i) Subject agrees not to start a new exercise program for the duration of the study; j) Subject is dependable and able to follow directions as outlined in the protocol and usage instructions provided by the Sponsor; k) Subject is willing to participate in all study evaluations; l) Subject is in generally good health and has a current Panelist Profile Form on file at ECRL; m) Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164; n) Subjects understands and is willing to sign an Informed Consent Form in conformance with 21 CRF Part 50: "Protection of Human Subjects."

Exclusion criteria

Exclusion criteria: a) Female subject (if applicable) is pregnant, nursing, planning a pregnancy, or not using adequate birth control; b) Subject has received treatment with sympathomimetics, antihistamines, vasoconstrictors, non-steroidal anti-inflammatory agents, and/or systemic or topical corticosteroids within one week prior to initiation of the study; c) Subject has a history of acute or chronic dermatologic, medical, and/or physical conditions which would preclude application of the test material and/or could influence the outcome of the study; d) Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study; e) Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs; f) Subject has a history of skin cancer, or is currently undergoing treatment for active cancer of any kind; g) Subject has insulin-dependent diabetes.

Design outcomes

Primary

MeasureTime frame
Dermal evaluation by a dermatologist before and 4 weeks after use of a test material.

Countries

North America

Contacts

Public ContactAKINORI INOUE

Lion Corporation Global Development Center

ino-aki@lion.co.jp08012731828

Outcome results

None listed

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