Dermal Irritation, Sensitization and Cumulative Irritation Potential of 6% Bemotrizinol (NCT05260359) | Clinical Trial Compass
CompletedPhase 2
Dermal Irritation, Sensitization and Cumulative Irritation Potential of 6% Bemotrizinol
United States224 participantsStarted 2022-02-23
Plain-language summary
The purpose of this clinical trial is to evaluate the dermal safety of Bemotrizinol (6%).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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;
Exclusion criteria
. Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the dermal irritation (erythema) potential of 6% BEMT over 21 days
Timeframe: 21 days
2
Determine the dermal sensitization potential of 6% BEMT after 24 hours
Timeframe: 24 hours
3
Determine the dermal sensitization potential of 6% BEMT after 48 hours
Timeframe: 48 hours
4
Determine the dermal sensitization potential of 6% BEMT after 72 hours
Timeframe: 72 hours
5
Determine the dermal sensitization potential of 6% BEMT after 96 hours
Timeframe: 96 hours
6
Determine the cumulative irritation potential of 6% BEMT over 21 days
. 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.);