Status:
COMPLETED
Dermal Irritation, Sensitization and Cumulative Irritation Potential of 6% Bemotrizinol
Lead Sponsor:
DSM Nutritional Products, Inc.
Conditions:
Sunburn
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this clinical trial is to evaluate the dermal safety of Bemotrizinol (6%).
Detailed Description
The first objective of this study is to determine if 6% Bemotrizinol (BEMT) either in a basic sunscreen oil formulation (SU E 101413 85) or as dispersion in petrolatum (SU-E-101413-82) elicit dermal i...
Eligibility Criteria
Inclusion
- Subject is male or female between 18 and 75 years of age;
- Subject does not exhibit any skin diseases or abnormalities which might be confused with a skin reaction from the test material;
- 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 agrees to refrain from getting patches wet, scrubbing or washing the test area with soap, and applying powders, lotions or personal care products to the area during the course of the study;
- Subject agrees not to introduce any new cosmetic or toiletry products during the study;
- Subject is dependable and able to follow directions as outlined in the protocol;
- Subject is willing to participate in all study evaluations;
- Subject is in generally good health and has a current Panelist Profile Form and Medical History Form on file at CRL;
- Subject has completed a HIPAA Authorization Form in conformance with 45 code of federal regulation (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;
- Subject has a known allergy to any of the formulation ingredients; Ingredients INCI names: BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE; ALCOHOL; C12-15 ALKYL BENZOATE; CAPRYLIC/CAPRIC TRIGLYCERIDE; DICAPRYLYL CARBONATE; ISOPROPYL MYRISTATE; PETROLATUM; PHENETHYL BENZOATE;
- 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 (including active eczema or psoriasis on the test sites), 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 has scheduled, or is planning to undergo, any medical or surgical procedures during the 7 week course of the study
- Subject exhibits birthmarks, moles, vitiligo, keloids, or any dermal markings on the back that might interfere with grading;
- Subject has a known communicable disease (e.g., HIV, sexually transmitted diseases, Hepatitis B, Hepatitis C, etc.);
- Subject is an insulin-dependent diabetic;
- Subject has a history of skin cancer or is currently undergoing treatment for active cancer of any type;
- 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 skin treatment products or cosmetics, toiletries, and/or topical drugs.
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2022
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT05260359
Start Date
February 23 2022
End Date
April 8 2022
Last Update
August 26 2022
Active Locations (1)
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1
Eurofins | CRL, Inc.
Piscataway, New Jersey, United States, 08854