Dermal Irritation, Sensitization and Cumulative Irritation Potential of 6% Bemotrizinol

NCT05260359 | Completed Phase 2 FDA Drug

• 1 other identifier: DSM RIPT 2020
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to evaluate the dermal safety of Bemotrizinol (6%).

Conditions

Sunburn

Keywords

cumulative irritation; irritation; sensitization; Bemotrizinol; Sunscreen

Outcome Measures

Primary Outcomes (6)

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

  Dermal irritation and/or sensitization rated based on following scoring system: 0 - No evidence of irritation 1. \- Minimal erythema, barely perceptible 2. \- Definite erythema, readily visible; minimal edema or minimal papular response 3. \- Erythema and papules 4. \- Definite edema 5. \- Erythema, edema, and papules 6. \- Vesicular eruption 7. \- Strong reaction spreading beyond test site

  21 days

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

  After a 14 day rest period, a challenge test will be given to look at signals of a sensitization response measured by using the following scoring system: 0 - No evidence of irritation 1. \- Minimal erythema, barely perceptible 2. \- Definite erythema, readily visible; minimal edema or minimal papular response 3. \- Erythema and papules 4. \- Definite edema 5. \- Erythema, edema, and papules 6. \- Vesicular eruption 7. \- Strong reaction spreading beyond test site

  24 hours

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

  After a 14 day rest period, a challenge test will be given to look at signals of a sensitization response measured by using the following scoring system: 0 - No evidence of irritation 1. \- Minimal erythema, barely perceptible 2. \- Definite erythema, readily visible; minimal edema or minimal papular response 3. \- Erythema and papules 4. \- Definite edema 5. \- Erythema, edema, and papules 6. \- Vesicular eruption 7. \- Strong reaction spreading beyond test site

  48 hours

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

  After a 14 day rest period, a challenge test will be given to look at signals of a sensitization response measured by using the following scoring system: 0 - No evidence of irritation 1. \- Minimal erythema, barely perceptible 2. \- Definite erythema, readily visible; minimal edema or minimal papular response 3. \- Erythema and papules 4. \- Definite edema 5. \- Erythema, edema, and papules 6. \- Vesicular eruption 7. \- Strong reaction spreading beyond test site

  72 hours

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

  After a 14 day rest period, a challenge test will be given to look at signals of a sensitization response measured by using the following scoring system: 0 - No evidence of irritation 1. \- Minimal erythema, barely perceptible 2. \- Definite erythema, readily visible; minimal edema or minimal papular response 3. \- Erythema and papules 4. \- Definite edema 5. \- Erythema, edema, and papules 6. \- Vesicular eruption 7. \- Strong reaction spreading beyond test site

  96 hours

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

  The cumulative irritation potential of 6% bemotrizinol (BEMT) will be assessed for each subject via a visual assessment of the test products and controls during a 21-day application period. Cumulative irritation potential will be assessed using the following scoring system: 0 - No evidence of irritation 1. \- Minimal erythema, barely perceptible 2. \- Definite erythema, readily visible; minimal edema or minimal papular response 3. \- Erythema and papules 4. \- Definite edema 5. \- Erythema, edema, and papules 6. \- Vesicular eruption 7. \- Strong reaction spreading beyond test site

  21 days

Study Arms (2)

6% BEMT HRIPT

ACTIVE COMPARATOR

During the challenge phase of the HRIPT portion of the study, there will be 6 patches (2 product patches, 2 vehicle controls. 1 saline control and 1 empty patch), leaving out the positive control.

Drug: 6% Bemotrizinol (BEMT) in a basic sunscreen oil formulation; Drug: 6% Bemotrizinol (BEMT) dispersion in petrolatum; Other: Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT; Other: Petrolatum vehicle; Other: 0.9% Saline; Other: Undosed patch

6% BEMT Cumulative Irritation Study

ACTIVE COMPARATOR

During the Cumulative Irritation portion of the study there will be 7 patches (2 product patches, 2 vehicle controls, 1 positive control, 1 low-irritancy control, and 1 empty patch). The low-irritancy control patch will be a saline patch. The positive control will be a SLS patch. The negative control will be an undosed patch.

Drug: 6% Bemotrizinol (BEMT) in a basic sunscreen oil formulation; Drug: 6% Bemotrizinol (BEMT) dispersion in petrolatum; Other: Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT; Other: Petrolatum vehicle; Other: 0.9% Saline; Other: Sodium Lauryl Sulfate 0.1% (SLS); Other: Undosed patch

Interventions

6% Bemotrizinol (BEMT) in a basic sunscreen oil formulation DRUG

SU E 101413 85

Also known as: PARSOL® SHIELD

6% BEMT Cumulative Irritation Study; 6% BEMT HRIPT

6% Bemotrizinol (BEMT) dispersion in petrolatum DRUG

SU-E-101413-82

Also known as: PARSOL® SHIELD

6% BEMT Cumulative Irritation Study; 6% BEMT HRIPT

Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT OTHER

SU E 101413 91

Also known as: Sunscreen oil Vehicle

6% BEMT Cumulative Irritation Study; 6% BEMT HRIPT

Petrolatum vehicle OTHER

SU-E-101413-83

Also known as: Vehicle

6% BEMT Cumulative Irritation Study; 6% BEMT HRIPT

0.9% Saline OTHER

low irritancy control

Also known as: Saline

6% BEMT Cumulative Irritation Study; 6% BEMT HRIPT

Sodium Lauryl Sulfate 0.1% (SLS) OTHER

positive control

Also known as: control

6% BEMT Cumulative Irritation Study

Undosed patch OTHER

negative control

Also known as: control

6% BEMT Cumulative Irritation Study; 6% BEMT HRIPT

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 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;
• Subject has completed a HIPAA Authorization Form in conformance with 45 code of federal regulation (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;
• 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.);
• Subject is an insulin-dependent diabetic;
• Subject has a history of skin cancer or is currently undergoing treatment for active cancer of any type;
• 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 skin treatment products or cosmetics, toiletries, and/or topical drugs.

Sponsors & Collaborators

• DSM Nutritional Products, Inc.: lead

Study Sites (1)

Eurofins | CRL, Inc.

Piscataway, New Jersey, 08854, United States

Location

Related Publications (2)

• McNamee PM, Api AM, Basketter DA, Frank Gerberick G, Gilpin DA, Hall BM, Jowsey I, Robinson MK. A review of critical factors in the conduct and interpretation of the human repeat insult patch test. Regul Toxicol Pharmacol. 2008 Oct;52(1):24-34. doi: 10.1016/j.yrtph.2007.10.019. Epub 2007 Dec 4.

  PMID: 18639964 BACKGROUND

• Api AM, Vey M. Implementation of the dermal sensitization Quantitative Risk Assessment (QRA) for fragrance ingredients. Regul Toxicol Pharmacol. 2008 Oct;52(1):53-61. doi: 10.1016/j.yrtph.2008.05.011. Epub 2008 May 27.

  PMID: 18635300 BACKGROUND

Related Links

• Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Nonprescription Sunscreen Drug Products - Safety and Effectiveness Data.
• U.S. Department of Health and Human Services. Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Guidance for Industry. 2018.

MeSH Terms

Conditions

Sunburn

Interventions

bis-ethylhexyloxyphenol methoxyphenyl triazine; Petrolatum; Sunscreening Agents; Ethanol; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Photosensitivity Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Burns; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals; Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Dermatologic Agents; Therapeutic Uses; Cosmetics; Specialty Uses of Chemicals; Alcohols; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Samantha Poweski

  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: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A 21-Day controlled study to evaluate the skin Irritation and sensitization potential of 6% Bemotrizinol (BEMT) in topical products with vehicle controls after repeated patch applications to healthy human participants by following conventional Repeated Insult (HRIPT) and Cumulative Irritation (CIT) methodologies.

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: March 2, 2022
• Study Start: February 23, 2022
• Primary Completion: April 8, 2022
• Study Completion: April 8, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)