A Phase 2 interventional study of 6% Bemotrizinol (BEMT) in a basic sunscreen oil formulation and 6% Bemotrizinol (BEMT) dispersion in petrolatum in Sunburn, sponsored by DSM Nutritional Products, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-26.
Sponsored by DSM Nutritional Products, Inc. (part of dsm-firmenich) · Phase 2, Interventional, and Screening
The purpose of this clinical trial is to evaluate the dermal safety of Bemotrizinol (6%).
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.
29 studies on the registry are indexed under Sunburn; 2 are open to participants now.
This study's enrollment of 224 is above the median of 54 across 26 interventional studies indexed under Sunburn.
Browse Sunburn studies →DSM Nutritional Products, Inc. is the lead sponsor of 35 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
First submitted before DSM Nutritional Products, Inc. became part of dsm-firmenich.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
SU E 101413 85
Also known as: PARSOL® SHIELD
SU-E-101413-82
Also known as: PARSOL® SHIELD
SU E 101413 91
Also known as: Sunscreen oil Vehicle
SU-E-101413-83
Also known as: Vehicle
low irritancy control
Also known as: Saline
positive control
Also known as: control
negative control
Also known as: control
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 21 days
Plan to share: No
Ran from Feb 2022 to primary completion in Apr 2022, 1 month.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
DSM Nutritional Products, Inc. →