Photoallergic Potential of 6% Bemotrizinol

Completed · Phase 2

Conditions studied: Photoallergic Response

In brief

This clinical trial will assess the photoallergic potential of BEMT (6%), compared to a vehicle control and a negative control.

Key facts

Study ID

NCT05254912

Run by

dsm-firmenich Switzerland AG

People needed

50

Starts

2022-03-07

Expected to finish

2022-04-22

Last updated by the study team

2022-08-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject is male or female between 18 and 75 years of age;
• Subject has a Fitzpatrick Skin Types I - III, based on the first 30 to 45 minutes of sun exposure after a winter season of no sun exposure according to the following criteria; I Always burns easily; never tans (sensitive) II Always burns easily; tans minimally (sensitive) III Burns moderately; tans gradually (normal)
• Subject agrees to avoid excessive sun exposure of the test sites and to refrain from visits to tanning salons during the course of this study;
• Subject does not exhibit any skin diseases or abnormalities which might be confused with a skin reaction from the test material;
• Subject agrees not to introduce any new cosmetic or toiletry products during the study;
• Subject agrees to refrain from getting patches wet and from scrubbing or washing the test area with soap or applying powders, lotions or personal care products to the area during the course of the study;
• Subject is dependable and able to follow directions as outlined in the protocol and anticipates being available for all study visits;
• Subject is willing to participate in all study evaluations;
• Subject is in generally good health and has a current Panelist Profile Form on file at CRL;
• Subject has completed a HIPAA Authorization Form in conformance with 45 CFR Parts 160 and 164;
• Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: "Protection of Human Subjects."

You may not qualify if…

• Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
• Subjects with a prior history of phototoxic or photoallergic reactions or those taking medication which might produce an abnormal response to sunlight;
• 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;
• 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;
• Subject is under treatment for a skin and/or systemic bacterial infection;
• Subject reports a history of allergies to tape adhesives;
• Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
• Subject has known allergies to sunscreen, skin treatment products or cosmetics, toiletries, and/or topical drugs;
• Subject has a known communicable disease (e.g., HIV, sexually transmitted diseases, Hepatitis B, Hepatitis C, etc.);
• Subject has insulin-dependent diabetes;
• Subject has a history of cancer;
• Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
• Subject exhibits sunburn, suntan, uneven skin tone, blemishes, moles or excess hair in the test site area.

Where it is running

• Eurofins | CRL, Inc. — Piscataway, New Jersey, United States

Full record on ClinicalTrials.gov

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