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SunburnPhase 2NCT05260359

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

A Phase 2 study testing 6% Bemotrizinol (BEMT) in a basic sunscreen oil formulation, 6% Bemotrizinol (BEMT) dispersion in petrolatum and 0.9% Saline in people with Sunburn, run by dsm-firmenich Switzerland AG at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Sunburn
What is being tested?
6% Bemotrizinol (BEMT) in a basic sunscreen oil formulation, 6% Bemotrizinol (BEMT) dispersion in petrolatum and 0.9% Saline
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
1 siteUnited States
Study dates
23 Feb 2022to 8 Apr 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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."

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Eurofins | CRL, Inc.

    Piscataway, New Jersey, 08854

Other trials in United States

About this study

Official title: 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%).

Read the 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.

Conditions
Sunburn
Being tested
6% Bemotrizinol (BEMT) in a basic sunscreen oil formulation, 6% Bemotrizinol (BEMT) dispersion in petrolatum, Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT, Petrolatum vehicle, 0.9% Saline
Keywords
cumulative irritation, irritation, sensitization, Bemotrizinol, Sunscreen
Medical subject headings
Sunburn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 6% Bemotrizinol (BEMT) in a basic sunscreen oil formulationDrug

    Also called PARSOL® SHIELD

    SU E 101413 85

  • 6% Bemotrizinol (BEMT) dispersion in petrolatumDrug

    Also called PARSOL® SHIELD

    SU-E-101413-82

  • Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMTOther

    Also called Sunscreen oil Vehicle

    SU E 101413 91

  • Petrolatum vehicleOther

    Also called Vehicle

    SU-E-101413-83

  • 0.9% SalineOther

    Also called Saline

    low irritancy control

  • Sodium Lauryl Sulfate 0.1% (SLS)Other

    Also called control

    positive control

  • Undosed patchOther

    Also called control

    negative control

Study groups in NCT05260359
Study groupRoleWhat they receive
6% BEMT HRIPTActive comparatorDuring 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.
Receives: 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 StudyActive comparatorDuring 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 21 days

  2. 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

    Measured: 24 hours

  3. 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

    Measured: 48 hours

  4. 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

    Measured: 72 hours

  5. 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

    Measured: 96 hours

  6. 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

    Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start23 Feb 2022
  3. Primary completion8 Apr 2022
  4. Study completion8 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Single group
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05260359
Sponsor's protocol ID
DSM RIPT 2020
Status last verified
Aug 2022
First submitted
11 Feb 2022
Last updated
26 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18639964

  • 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.

    PubMed 18635300

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 6% Bemotrizinol (BEMT) in a basic sunscreen oil formulation, 6% Bemotrizinol (BEMT) dispersion in petrolatum and 0.9% Saline in people with Sunburn, run by dsm-firmenich Switzerland AG at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the dermal irritation (erythema) potential of 6% BEMT over 21 days (time frame: 21 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05260359, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.

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