CompletedPhase 2

Phototoxicity Potential of 6% Bemotrizinol

United States34 participantsStarted 2022-02-28

Plain-language summary

Phototoxicity Potential of Bemotrizinol (6%)

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.

✓. 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;

✕. 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;

Determination of the Photoxicity potential of 6% Bemotrizinol 24 hours post-irradiation

Timeframe: Phototoxic response will be checked 24 hours post-irradiation

Determination of the Photoxicity potential of 6% Bemotrizinol 48 hours post-irradiation

Timeframe: Phototoxic response will be checked 48 hours post-irradiation

NCT IDNCT05254925

Sponsordsm-firmenich Switzerland AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-03

Who can participate