Photoallergic Potential of 6% Bemotrizinol

NCT05254912 | Completed Phase 2 FDA Drug

• 1 other identifier: DSM PA 2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will assess the photoallergic potential of BEMT (6%), compared to a vehicle control and a negative control.

Conditions

Photoallergic Response

Keywords

Sunscreen, photoprotective, UV-filter

Outcome Measures

Primary Outcomes (3)

• Photoallergy potential of a BEMT (6%) formulation based on a dermal scoring system 24 hours post irradiation

  Photoallergenicity conclusions (i.e., "Photoallergic Response" or "Not a contact sensitizer or photoallergen") will 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. 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

  Photoallergy response will be evaluated 24 hours post irradiation

• Photoallergy potential of a BEMT (6%) formulation based on a dermal scoring system 48 hours post irradiation

  Photoallergenicity conclusions (i.e., "Photoallergic Response" or "Not a contact sensitizer or photoallergen") will 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. 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

  Photoallergy response will be evaluated at 48 hours post irradiation

• Photoallergy potential of a BEMT (6%) formulation based on a dermal scoring system 72 hours post irradiation

  Photoallergenicity conclusions (i.e., "Photoallergic Response" or "Not a contact sensitizer or photoallergen") will 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. 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

  Photoallergy response will be evaluated at 72 hours post irradiation

Study Arms (3)

6% BEMT in sunscreen oil (SU E 101413 85)

ACTIVE COMPARATOR

Assess the photoallergic potential of Sunscreen oil with 6% BEMT (PARSOL® Shield) and 10% ethanol as penetration enhancer a test material (formulation: SU E 101413 85). Approximately 0.15 g or 0.15 ml of each product and vehicle control will be applied. Two doses (one irradiated and one non- irradiated) of the investigational products and two doses (one irradiated and one non- irradiated) of the vehicle controls will be applied to back of each subject once on Day 1 under occlusive patches. Patches will remain in place for approximately 24 hours and will be removed by clinical study staff on Day 2. During the challenge phase, two undosed negative control occlusive patches will also be also applied. Subjects will return to the laboratory 24 hours and 48 hours post-irradiation for dermal evaluations. Dermal scores obtained during the challenge phase will be reported for each site.

Drug: 6% Bemotrizinol in sunscreen formulation

Sunscreen oil Vehicle (SU E 101413 91)

OTHER

Vehicle Control: Assess the photoallergenic potential of sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT. Approximately 0.15 g or 0.15 ml of each product and vehicle control will be applied. Two doses (one irradiated and one non- irradiated) of the investigational products and two doses (one irradiated and one non- irradiated) of the vehicle controls will be applied to back of each subject once on Day 1 under occlusive patches. Patches will remain in place for approximately 24 hours and will be removed by clinical study staff on Day 2. During the challenge phase, two undosed negative control occlusive patches will also be also applied. Subjects will return to the laboratory 24 hours and 48 hours post-irradiation for dermal evaluations. Dermal scores obtained during the challenge phase will be reported for each site.

Other: Vehicle

6% BEMT in petrolatum (SU E 101413 82)

ACTIVE COMPARATOR

Assess the photoallergenic potential of a dispersion of 6% BEMT (PARSOL® Shield) in petrolatum Approximately 0.15 g or 0.15 ml of each product and vehicle control will be applied. Two doses (one irradiated and one non- irradiated) of the investigational products and two doses (one irradiated and one non- irradiated) of the vehicle controls will be applied to back of each subject once on Day 1 under occlusive patches. Patches will remain in place for approximately 24 hours and will be removed by clinical study staff on Day 2. During the challenge phase, two undosed negative control occlusive patches will also be also applied. Subjects will return to the laboratory 24 hours and 48 hours post-irradiation for dermal evaluations. Dermal scores obtained during the challenge phase will be reported for each site.

Drug: 6% Bemotrizinol in petrolatum

Interventions

6% Bemotrizinol in sunscreen formulation DRUG

6% Bemotrizinol (BEMT) in a basic sunscreen oil formulation (SU E 101413 85)

Also known as: PARSOL SHIELD

6% BEMT in sunscreen oil (SU E 101413 85)

6% Bemotrizinol in petrolatum DRUG

6% Bemotrizinol (BEMT) as a dispersion in petrolatum (SU-E-101413-82)

Also known as: PARSOL SHIELD

6% BEMT in petrolatum (SU E 101413 82)

Vehicle OTHER

Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT (SU E 101413 91)

Sunscreen oil Vehicle (SU E 101413 91)

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

bis-ethylhexyloxyphenol methoxyphenyl triazine; Petrolatum

Intervention Hierarchy (Ancestors)

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. The Investigatory staff will not be blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will evaluate the potential of an investigational product (6% Bemotrizinol (BEMT) in a suitable vehicle (i.e., sunscreen oil SU E 101413 85) or petrolatum (SU-E-101413-82)) to produce a photoallergic response after application to the skin of human subjects followed by exposure to UV radiation.

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 24, 2022
• Study Start: March 7, 2022
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)