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

August 25, 2022 updated by: DSM Nutritional Products, Inc.

Evaluation Bemotrizinol in Human Repeated Insult Patch Test (HRIPT) and Cumulative Irritation Test

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

Study Overview

Detailed Description

The first objective of this study is to determine if 6% Bemotrizinol (BEMT) either in a basic sunscreen oil formulation (SU E 101413 85) or as dispersion in petrolatum (SU-E-101413-82) elicit dermal irritation and/or induce sensitization following repeated patch application.

The second objective of this study is to determine the cumulative irritation potential of 6% BEMT either in a basic sunscreen oil formulation (SU E 101413 85) or as dispersion in petrolatum (SU-E-101413-82) topically applied to the skin of human subjects over a 21-day period via a Human Repeat Insult Patch Test (HRIPT).

HRIPT: This part of the study will consist of an Induction Phase, a Challenge Phase, and, at the discretion of the Principal Investigator, a Re-Challenge Phase. During the Induction Phase, the test material will be applied to the same location on the back of each subject three times per week for a total of nine applications with 24 to 48 hour rest periods. Test sites will be examined for dermal irritation at each visit prior to reapplication of the test material. Approximately 14 days after the final visit of the Induction Phase, subjects will return to the laboratory for the Challenge Phase. The test material will be applied to a naïve site on the back under an appropriate patch and will be removed by clinical staff approximately 24 hours later. Test sites will be examined for signs of dermal irritation or sensitization. A subject may be required to return to the laboratory for a Re-Challenge Test, if reactions indicative of sensitization are observed during the Challenge Phase. During the Re-Challenge Phase, the test material will be applied to a naïve site under the same conditions of the Challenge Phase, and the subject will be examined for dermal reactions.

Cumulative Irritation Study: A subset of individuals selected for the HRIPT study will also participate in the Cumulative Irritation Study. Subjects who meet inclusion and exclusion criteria will be enrolled. Subjects will be consented and screened to determine eligibility and qualified subjects will be enrolled. Subjects will participate in a 21-day cumulative irritation patch study on the back. Test products and vehicle patches, along with a high irritancy, a low irritancy and empty patch controls, will be tested during the study.

At the Day 1 Visit, the upper back of each subject (between the scapulae to either side of the spinal midline) will be wiped with 70% isopropyl alcohol and allowed to dry. The empty patch, low irritancy 0.9% Saline control and the high irritancy Sodium Lauryl Sulfate 0.1% (SLS) control will be used as negative and positive controls, respectively. Controls and test products will be applied to the back daily, for approximately 21 days. Patches will remain in place for a period of approximately 24 hours. Test sites will be graded following each patch removal.

The vehicle controls (SU E 101413 91 and SU-E-101413-83), 0.9% saline and empty patches as negative control will be used for the HRIPT and Cumulative Irritation portion of the study. The 0.1% Sodium Laurel Sulfate (SLS) will be only used for the Cumulative Irritation portion of the study.

Approximately 0.2 g of the investigational products and the vehicle control will each be applied to the fabric portion of separate patches.

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.

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.

The patches to be used for this clinical trial will be occlusive strips (manufactured by Strukmyer LLC, Mesquite, TX or equivalent), consisting of a breathable tape with non- breathable adhesive and center portion of 1.9 cm x 1.9 cm fabric.

Dermal scores will be reported for each site.

Safety of the investigational products will be monitored by evaluating adverse event reporting.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Eurofins | CRL, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is male or female between 18 and 75 years of age;
  2. Subject does not exhibit any skin diseases or abnormalities which might be confused with a skin reaction from the test material;
  3. 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;
  4. 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;
  5. Subject agrees not to introduce any new cosmetic or toiletry products during the study;
  6. Subject is dependable and able to follow directions as outlined in the protocol;
  7. Subject is willing to participate in all study evaluations;
  8. Subject is in generally good health and has a current Panelist Profile Form and Medical History Form on file at CRL;
  9. Subject has completed a HIPAA Authorization Form in conformance with 45 code of federal regulation (CFR) Parts 160 and 164;
  10. Subject understands and is willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: "Protection of Human Subjects."

Exclusion Criteria:

  1. Female subject is pregnant, nursing, planning a pregnancy, or not using adequate birth control;
  2. 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;
  3. 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;
  4. 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;
  5. Subject is under treatment for a skin and/or systemic bacterial infection;
  6. Subject has scheduled, or is planning to undergo, any medical or surgical procedures during the 7 week course of the study
  7. Subject exhibits birthmarks, moles, vitiligo, keloids, or any dermal markings on the back that might interfere with grading;
  8. Subject has a known communicable disease (e.g., HIV, sexually transmitted diseases, Hepatitis B, Hepatitis C, etc.);
  9. Subject is an insulin-dependent diabetic;
  10. Subject has a history of skin cancer or is currently undergoing treatment for active cancer of any type;
  11. Subject reports a history of allergies to tape adhesives;
  12. Subject is currently taking certain medications which, in the opinion of the Principal Investigator, may interfere with the study;
  13. Subject has known allergies to skin treatment products or cosmetics, toiletries, and/or topical drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 6% BEMT HRIPT
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.
SU E 101413 85
Other Names:
  • PARSOL® SHIELD
SU-E-101413-82
Other Names:
  • PARSOL® SHIELD
SU E 101413 91
Other Names:
  • Sunscreen oil Vehicle
SU-E-101413-83
Other Names:
  • Vehicle
low irritancy control
Other Names:
  • Saline
negative control
Other Names:
  • control
Active Comparator: 6% BEMT Cumulative Irritation Study
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.
SU E 101413 85
Other Names:
  • PARSOL® SHIELD
SU-E-101413-82
Other Names:
  • PARSOL® SHIELD
SU E 101413 91
Other Names:
  • Sunscreen oil Vehicle
SU-E-101413-83
Other Names:
  • Vehicle
low irritancy control
Other Names:
  • Saline
negative control
Other Names:
  • control
positive control
Other Names:
  • control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the dermal irritation (erythema) potential of 6% BEMT over 21 days
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Samantha Poweski, Eurofins CRL Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2022

Primary Completion (Actual)

April 8, 2022

Study Completion (Actual)

April 8, 2022

Study Registration Dates

First Submitted

February 11, 2022

First Submitted That Met QC Criteria

February 25, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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