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 range18 Years – 75 Years

SexALL

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;
✕. 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.);

What they're measuring

Determine the dermal irritation (erythema) potential of 6% BEMT over 21 days

Timeframe: 21 days

Determine the dermal sensitization potential of 6% BEMT after 24 hours

Timeframe: 24 hours

Determine the dermal sensitization potential of 6% BEMT after 48 hours

Timeframe: 48 hours

Determine the dermal sensitization potential of 6% BEMT after 72 hours

Timeframe: 72 hours

Determine the dermal sensitization potential of 6% BEMT after 96 hours

Timeframe: 96 hours

Determine the cumulative irritation potential of 6% BEMT over 21 days

Timeframe: 21 days

Trial details

NCT IDNCT05260359

Sponsordsm-firmenich Switzerland AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-08

View on ClinicalTrials.gov More Sunburn trials

Who can participate

Age range18 Years – 75 Years

SexALL

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;
✕. 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.);

What they're measuring

Determine the dermal irritation (erythema) potential of 6% BEMT over 21 days

Timeframe: 21 days

Determine the dermal sensitization potential of 6% BEMT after 24 hours

Timeframe: 24 hours

Determine the dermal sensitization potential of 6% BEMT after 48 hours

Timeframe: 48 hours

Determine the dermal sensitization potential of 6% BEMT after 72 hours

Timeframe: 72 hours

Determine the dermal sensitization potential of 6% BEMT after 96 hours

Timeframe: 96 hours

Determine the cumulative irritation potential of 6% BEMT over 21 days

Timeframe: 21 days