Phototoxicity Potential of 6% Bemotrizinol

NCT05254925 | Completed Phase 2 FDA Drug

• 1 other identifier: DSM PT 2020
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Phototoxicity Potential of Bemotrizinol (6%)

Conditions

Phototoxic Response

Outcome Measures

Primary Outcomes (2)

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

  Phototoxic response based on a comparison of the reactions obtained on treated/irradiated, treated/non-irradiated and non-treated control sites Investigational product safety will be determined through interpretation of the dermal evaluation scores. Dermal scores will be reported as either Phototoxic or Non-Phototoxic responses and the following dermal scoring system will be used to evaluate the irradiated area within the treated test site: Grading scale for Erythema: "0" = No visible skin reaction; "+" = Barely perceptible erythema; "1+" = Mild erythema; "2+" = Well defined erythema; "3+" = Severe erythema Grading Scale for dermal response: e = Edema P = Peeling S = Spreading of reaction beyond irradiated site. Sc = Scabbing d = Dryness/scaling D = Oozing, crusting, and/or superficial erosions I = Itching Pa = Papules V = Vesicle W = Weeping Hr = Hyperpigmentation Ho = Hypopigmentation M = Missed Visit

  Phototoxic response will be checked 24 hours post-irradiation

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

  Phototoxic response based on a comparison of the reactions obtained on treated/irradiated, treated/non-irradiated and non-treated control sites Investigational product safety will be determined through interpretation of the dermal evaluation scores. Dermal scores will be reported as either Phototoxic or Non-Phototoxic responses and the following dermal scoring system will be used to evaluate the irradiated area within the treated test site: Grading scale for Erythema: "0" = No visible skin reaction; "+" = Barely perceptible erythema; "1+" = Mild erythema; "2+" = Well defined erythema; "3+" = Severe erythema Grading Scale for dermal response: e = Edema P = Peeling S = Spreading of reaction beyond irradiated site. Sc = Scabbing d = Dryness/scaling D = Oozing, crusting, and/or superficial erosions I = Itching Pa = Papules V = Vesicle W = Weeping Hr = Hyperpigmentation Ho = Hypopigmentation M = Missed Visit

  Phototoxic response will be checked 48 hours post-irradiation

Study Arms (4)

Phototoxicity evaluation of sunscreen oil with 6% BEMT (SU E 101413 85)

ACTIVE COMPARATOR

Assessment of the phototoxicity potential of sunscreen oil with 6% BEMT (PARSOL® Shield) and 10% ethanol as penetration enhancer a test material (formulation: SU E 101413 85). The phototoxic response of the investigational product: SU E 101413 85 will be assessed following the determination of each subject's Minimal Erythema Dose (MED). Approximately 0.15 g or 0.15 ml of the investigational product will be applied to the skin of human subjects which will then be exposed to UV radiation an a erythema and dermal response scoring system will be used to evaluate the phototoxic response of the irradiated area within the treated test site of each subject.

Drug: Sunscreen oil with 6% Bemotrizinol

Phototoxicity evaluation of sunscreen oil vehicle (SU E 101413 91)

OTHER

Vehicle Control: Assessment of the phototoxicity potential of sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT (formulation: SU E 101413 91). The phototoxic response of the investigational product: SU E 101413 91 will be assessed following the determination of each subject's Minimal Erythema Dose (MED). Approximately 0.15 g or 0.15 ml of the investigational product will be applied to the skin of human subjects which will then be exposed to UV radiation an a erythema and dermal response scoring system will be used to evaluate the phototoxic response of the irradiated area within the treated test site of each subject.

Other: Sunscreen oil vehicle

Phototoxicity evaluation of dispersion of 6% BEMT in petrolatum (SU E 101413 82)

ACTIVE COMPARATOR

Assessment of the phototoxicity potential of a dispersion of 6% BEMT (PARSOL® Shield) in petrolatum (formulation: SU E 101413 82). The phototoxic response of the investigational product: SU E 101413 82 will be assessed following the determination of each subject's Minimal Erythema Dose (MED). Approximately 0.15 g or 0.15 ml of the investigational product will be applied to the skin of human subjects which will then be exposed to UV radiation an a erythema and dermal response scoring system will be used to evaluate the phototoxic response of the irradiated area within the treated test site of each subject.

Drug: Dispersion of 6% BEMT in petrolatum

Phototoxicity evaluation of petrolatum vehicle (SU-E-101413-83)

OTHER

Vehicle Control: Assessment of the phototoxicity potential of petrolatum vehicle (SU-E-101413-83). The phototoxic response of the investigational product: SU E 101413 83 will be assessed following the determination of each subject's Minimal Erythema Dose (MED). Approximately 0.15 g or 0.15 ml of the investigational product will be applied to the skin of human subjects which will then be exposed to UV radiation an a erythema and dermal response scoring system will be used to evaluate the phototoxic response of the irradiated area within the treated test site of each subject.

Other: Petrolatum vehicle

Interventions

Sunscreen oil with 6% Bemotrizinol DRUG

Sunscreen oil with 6% BEMT (PARSOL® Shield) and 10% ethanol as penetration enhancer

Also known as: PARSOL® SHIELD, SU E 101413 85

Phototoxicity evaluation of sunscreen oil with 6% BEMT (SU E 101413 85)

Sunscreen oil vehicle OTHER

Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT (BEMT replaced by Isopropylmyristate)

Also known as: SU E 101413 91

Phototoxicity evaluation of sunscreen oil vehicle (SU E 101413 91)

Dispersion of 6% BEMT in petrolatum DRUG

Dispersion of 6% BEMT (PARSOL® Shield) in petrolatum

Also known as: PARSOL® SHIELD, SU-E-101413-82

Phototoxicity evaluation of dispersion of 6% BEMT in petrolatum (SU E 101413 82)

Petrolatum vehicle OTHER

Petrolatum vehicle

Also known as: SU-E-101413-83

Phototoxicity evaluation of petrolatum vehicle (SU-E-101413-83)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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."

You may not qualify if:

• 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.

Sponsors & Collaborators

• DSM Nutritional Products, Inc.: lead

Study Sites (1)

Eurofins | CRL, Inc.

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Interventions

Sunscreening Agents; bis-ethylhexyloxyphenol methoxyphenyl triazine; Petrolatum

Intervention Hierarchy (Ancestors)

Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals; Hydrocarbons; Organic Chemicals

Study Officials

• Rolf Schutz, PhD

  DSM Nutritional Products, Inc.

  STUDY DIRECTOR

• Gladys Osis, MT

  Eurofins CRL Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded to the name of the investigational products
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The potential of BEMT 6% to produce a phototoxic response will be assessed using a preestablished grading scale for erythema and dermal response following the application of approximately 0.15 g or 0.15 ml of each product (4 investigational treatments) on the skin of human subjects, which will then be exposed to UV radiation. Each study arm will include one of the following investigational treatments: a sunscreen oil with 6% BEMT and 10% ethanol as penetration enhancer (SU E 101413 85) as compared to a Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT (SU E 101413 91); a dispersion of 6% BEMT in petrolatum (SU E 101413 82); and petrolatum vehicle (SU E 101413 83).

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 24, 2022
• Study Start: February 28, 2022
• Primary Completion: March 3, 2022
• Study Completion: April 3, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)