Status:
COMPLETED
Phototoxicity Potential of 6% Bemotrizinol
Lead Sponsor:
DSM Nutritional Products, Inc.
Conditions:
Phototoxic Response
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Phototoxicity Potential of Bemotrizinol (6%)
Detailed Description
This clinical trial will assess the phototoxic potential of a test material, compared to a vehicle control and a negative control. The results obtained will determine if 6% bemotrizinol (BEMT) either ...
Eligibility Criteria
Inclusion
- 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."
Exclusion
- 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.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05254925
Start Date
February 28 2022
End Date
April 3 2022
Last Update
August 26 2022
Active Locations (1)
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1
Eurofins | CRL, Inc.
Piscataway, New Jersey, United States, 08854