Phototoxic ResponsePhase 2NCT05254925
Phototoxicity Potential of 6% Bemotrizinol
A Phase 2 study testing Sunscreen oil with 6% Bemotrizinol and Dispersion of 6% BEMT in petrolatum in people with Phototoxic Response, run by dsm-firmenich Switzerland AG at 1 site in United States.
Trial summary
Phototoxicity Potential 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
- Phototoxic Response
- What is being tested?
- Sunscreen oil with 6% Bemotrizinol and Dispersion of 6% BEMT in petrolatum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2022to 3 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 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;
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- 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."
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Topically Applied Bemotrizinol for Human Phototoxic Potential
Phototoxicity Potential of Bemotrizinol (6%)
Read the detailed description
This clinical trial will assess the phototoxic potential of a test material, compared to a vehicle control and a negative control. The results obtained will 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 a phototoxic response based on a comparison of the reactions obtained (either Phototoxic or non-Phototoxic) on the treated/irradiated, treated/non-irradiated and non- treated control sites. Two vehicle controls, i.e. sunscreen oil vehicle (SU E 101413 91) and petrolatum (SU E 101413 83), and a negative control will also be used as comparators in this clinical trial.
Duplicate test sites on the back (each approximately 4 cm2) will be identified via use of body map demonstrating application sites. Test material will be applied to designated patches and affixed to both sides of the back. In addition, 2 sets of patches without test material will be applied on 2 sides of the back. One side will be designated for irradiation, and the other is used as a treated/non-irradiated, and non-treated/non- irradiated control.
Approximately 24 hours after application, the patches will be removed and the skin will be gently wiped. The Minimal Erythema Dose (MED) will be determined from the five UV-treated sub-sites and all of the test sites will be evaluated according to the erythema grading scale. For evaluation of phototoxicity, the sites are irradiated with 0.5 of the subject's MED (full spectrum wavelengths UVB 290-320 nm and UVA 320-400 nm) followed by 5 J/cm2 UVA (320-400nm) using a Schott WG-345 and UG11/1 mm filter to block UVB wavelength 290-320 nanometers. The sites designated for irradiation will be then irradiated with solar simulated light by 0.5 times an individual's MED followed by 5 J/cm2 UVA.
Statistical analysis will not be performed for this study. Investigational product safety will be determined through interpretation of the dermal evaluation scores. Treated and control sites will be examined at 24 and 48 hours post-irradiation and graded according to a scoring scale.
If a grade ≥2+ erythema is observed after patch removal on the site designated for irradiation, the site will not be irradiated, regardless of the dermal response of the non-irradiated site and the subjects will be discontinued by the Principal Investigator from the study. The dermal response will be followed up until resolution or until the end of the study.
Dermal scores will be reported for each site. Clinically significant reactions other than phototoxic reactions will be recorded and interpreted accordingly and the safety of the investigational product will be monitored by evaluating adverse event reporting. An adverse event is any untoward medical occurrence, whether or not it is considered clinical trial related, including death, experienced by a subject. An event may consist of a disease, an exacerbation of a pre-existing illness or condition, an occurrence of an intermittent illness or condition, a set of related symptoms or signs, or a single symptom or sign. Any subject that presents with a dermal reaction of 3+ or greater will be considered as an adverse event and documented accordingly.
- Conditions
- Phototoxic Response
- Being tested
- Sunscreen oil with 6% Bemotrizinol, Sunscreen oil vehicle, Dispersion of 6% BEMT in petrolatum, Petrolatum vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunscreen oil with 6% BemotrizinolDrug
Also called PARSOL® SHIELD, SU E 101413 85
Sunscreen oil with 6% BEMT (PARSOL® Shield) and 10% ethanol as penetration enhancer
Sunscreen oil vehicleOther
Also called SU E 101413 91
Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT (BEMT replaced by Isopropylmyristate)
Dispersion of 6% BEMT in petrolatumDrug
Also called PARSOL® SHIELD, SU-E-101413-82
Dispersion of 6% BEMT (PARSOL® Shield) in petrolatum
Petrolatum vehicleOther
Also called SU-E-101413-83
Petrolatum vehicle
| Study group | Role | What they receive |
|---|---|---|
| Phototoxicity evaluation of sunscreen oil with 6% BEMT (SU E 101413 85) | Active comparator | Assessment of the phototoxicity potential of sunscreen oil with 6% BEMT (PARSOL® Shield) and 10% ethanol as penetration enhancer a test material (formulation: SU E 101413 85).
The phototoxic response of the investigational product: SU E 101413 85 will be assessed following the determination of each subject's Minimal Erythema Dose (MED). Approximately 0.15 g or 0.15 ml of the investigational product will be applied to the skin of human subjects which will then be exposed to UV radiation an a erythema and dermal response scoring system will be used to evaluate the phototoxic response of the irradiated area within the treated test site of each subject. Receives: Drug: Sunscreen oil with 6% Bemotrizinol |
| Phototoxicity evaluation of sunscreen oil vehicle (SU E 101413 91) | Other | Vehicle Control: Assessment of the phototoxicity potential of sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT (formulation: SU E 101413 91).
The phototoxic response of the investigational product: SU E 101413 91 will be assessed following the determination of each subject's Minimal Erythema Dose (MED). Approximately 0.15 g or 0.15 ml of the investigational product will be applied to the skin of human subjects which will then be exposed to UV radiation an a erythema and dermal response scoring system will be used to evaluate the phototoxic response of the irradiated area within the treated test site of each subject. Receives: Other: Sunscreen oil vehicle |
| Phototoxicity evaluation of dispersion of 6% BEMT in petrolatum (SU E 101413 82) | Active comparator | Assessment of the phototoxicity potential of a dispersion of 6% BEMT (PARSOL® Shield) in petrolatum (formulation: SU E 101413 82).
The phototoxic response of the investigational product: SU E 101413 82 will be assessed following the determination of each subject's Minimal Erythema Dose (MED). Approximately 0.15 g or 0.15 ml of the investigational product will be applied to the skin of human subjects which will then be exposed to UV radiation an a erythema and dermal response scoring system will be used to evaluate the phototoxic response of the irradiated area within the treated test site of each subject. Receives: Drug: Dispersion of 6% BEMT in petrolatum |
| Phototoxicity evaluation of petrolatum vehicle (SU-E-101413-83) | Other | Vehicle Control: Assessment of the phototoxicity potential of petrolatum vehicle (SU-E-101413-83).
The phototoxic response of the investigational product: SU E 101413 83 will be assessed following the determination of each subject's Minimal Erythema Dose (MED). Approximately 0.15 g or 0.15 ml of the investigational product will be applied to the skin of human subjects which will then be exposed to UV radiation an a erythema and dermal response scoring system will be used to evaluate the phototoxic response of the irradiated area within the treated test site of each subject. Receives: Other: Petrolatum vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the Photoxicity potential of 6% Bemotrizinol 24 hours post-irradiation
Phototoxic response 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. Dermal scores will be reported as either Phototoxic or Non-Phototoxic responses and 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
Measured: Phototoxic response will be checked 24 hours post-irradiation
Determination of the Photoxicity potential of 6% Bemotrizinol 48 hours post-irradiation
Phototoxic response 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. Dermal scores will be reported as either Phototoxic or Non-Phototoxic responses and 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
Measured: Phototoxic response will be checked 48 hours post-irradiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start28 Feb 2022
- Primary completion3 Mar 2022
- Study completion3 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phototoxic ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- The potential of BEMT 6% to produce a phototoxic response will be assessed using a preestablished grading scale for erythema and dermal response following the application of approximately 0.15 g or 0.15 ml of each product (4 investigational treatments) on the skin of human subjects, which will then be exposed to UV radiation. Each study arm will include one of the following investigational treatments: a sunscreen oil with 6% BEMT and 10% ethanol as penetration enhancer (SU E 101413 85) as compared to a Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT (SU E 101413 91); a dispersion of 6% BEMT in petrolatum (SU E 101413 82); and petrolatum vehicle (SU E 101413 83).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rolf Schutz, PhD, Study director, dsm-firmenich Switzerland AGGladys Osis, MT, Principal investigator, Eurofins CRL Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254925
- Sponsor's protocol ID
- DSM PT 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Topically Applied Bemotrizinol for Human Phototoxic Potential
- ClinicalTrials.gov ID
- NCT05254925
- Acronym / sponsor ID
- DSM PT 2020
- Conditions
- Phototoxic Response
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 3 Apr 2022 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phototoxicity Potential of Bemotrizinol (6%)
Detailed description
This clinical trial will assess the phototoxic potential of a test material, compared to a vehicle control and a negative control. The results obtained will 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 a phototoxic response based on a comparison of the reactions obtained (either Phototoxic or non-Phototoxic) on the treated/irradiated, treated/non-irradiated and non- treated control sites. Two vehicle controls, i.e. sunscreen oil vehicle (SU E 101413 91) and petrolatum (SU E 101413 83), and a negative control will also be used as comparators in this clinical trial.
Duplicate test sites on the back (each approximately 4 cm2) will be identified via use of body map demonstrating application sites. Test material will be applied to designated patches and affixed to both sides of the back. In addition, 2 sets of patches without test material will be applied on 2 sides of the back. One side will be designated for irradiation, and the other is used as a treated/non-irradiated, and non-treated/non- irradiated control.
Approximately 24 hours after application, the patches will be removed and the skin will be gently wiped. The Minimal Erythema Dose (MED) will be determined from the five UV-treated sub-sites and all of the test sites will be evaluated according to the erythema grading scale. For evaluation of phototoxicity, the sites are irradiated with 0.5 of the subject's MED (full spectrum wavelengths UVB 290-320 nm and UVA 320-400 nm) followed by 5 J/cm2 UVA (320-400nm) using a Schott WG-345 and UG11/1 mm filter to block UVB wavelength 290-320 nanometers. The sites designated for irradiation will be then irradiated with solar simulated light by 0.5 times an individual's MED followed by 5 J/cm2 UVA.
Statistical analysis will not be performed for this study. Investigational product safety will be determined through interpretation of the dermal evaluation scores. Treated and control sites will be examined at 24 and 48 hours post-irradiation and graded according to a scoring scale.
If a grade ≥2+ erythema is observed after patch removal on the site designated for irradiation, the site will not be irradiated, regardless of the dermal response of the non-irradiated site and the subjects will be discontinued by the Principal Investigator from the study. The dermal response will be followed up until resolution or until the end of the study.
Dermal scores will be reported for each site. Clinically significant reactions other than phototoxic reactions will be recorded and interpreted accordingly and the safety of the investigational product will be monitored by evaluating adverse event reporting. An adverse event is any untoward medical occurrence, whether or not it is considered clinical trial related, including death, experienced by a subject. An event may consist of a disease, an exacerbation of a pre-existing illness or condition, an occurrence of an intermittent illness or condition, a set of related symptoms or signs, or a single symptom or sign. Any subject that presents with a dermal reaction of 3+ or greater will be considered as an adverse event and documented accordingly.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The potential of BEMT 6% to produce a phototoxic response will be assessed using a preestablished grading scale for erythema and dermal response following the application of approximately 0.15 g or 0.15 ml of each product (4 investigational treatments) on the skin of human subjects, which will then be exposed to UV radiation. Each study arm will include one of the following investigational treatments: a sunscreen oil with 6% BEMT and 10% ethanol as penetration enhancer (SU E 101413 85) as compared to a Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT (SU E 101413 91); a dispersion of 6% BEMT in petrolatum (SU E 101413 82); and petrolatum vehicle (SU E 101413 83).
| Arm | Type | Receives |
|---|---|---|
| Phototoxicity evaluation of sunscreen oil with 6% BEMT (SU E 101413 85) | Active comparator | Drug: Sunscreen oil with 6% BemotrizinolAssessment of the phototoxicity potential of sunscreen oil with 6% BEMT (PARSOL® Shield) and 10% ethanol as penetration enhancer a test material (formulation: SU E 101413 85). The phototoxic response of the investigational product: SU E 101413 85 will be assessed following the determination of each subject's Minimal Erythema Dose (MED). Approximately 0.15 g or 0.15 ml of the investigational product will be applied to the skin of human subjects which will then be exposed to UV radiation an a erythema and dermal response scoring system will be used to evaluate the phototoxic response of the irradiated area within the treated test site of each subject. |
| Phototoxicity evaluation of sunscreen oil vehicle (SU E 101413 91) | Other | Other: Sunscreen oil vehicleVehicle Control: Assessment of the phototoxicity potential of sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT (formulation: SU E 101413 91). The phototoxic response of the investigational product: SU E 101413 91 will be assessed following the determination of each subject's Minimal Erythema Dose (MED). Approximately 0.15 g or 0.15 ml of the investigational product will be applied to the skin of human subjects which will then be exposed to UV radiation an a erythema and dermal response scoring system will be used to evaluate the phototoxic response of the irradiated area within the treated test site of each subject. |
| Phototoxicity evaluation of dispersion of 6% BEMT in petrolatum (SU E 101413 82) | Active comparator | Drug: Dispersion of 6% BEMT in petrolatumAssessment of the phototoxicity potential of a dispersion of 6% BEMT (PARSOL® Shield) in petrolatum (formulation: SU E 101413 82). The phototoxic response of the investigational product: SU E 101413 82 will be assessed following the determination of each subject's Minimal Erythema Dose (MED). Approximately 0.15 g or 0.15 ml of the investigational product will be applied to the skin of human subjects which will then be exposed to UV radiation an a erythema and dermal response scoring system will be used to evaluate the phototoxic response of the irradiated area within the treated test site of each subject. |
| Phototoxicity evaluation of petrolatum vehicle (SU-E-101413-83) | Other | Other: Petrolatum vehicleVehicle Control: Assessment of the phototoxicity potential of petrolatum vehicle (SU-E-101413-83). The phototoxic response of the investigational product: SU E 101413 83 will be assessed following the determination of each subject's Minimal Erythema Dose (MED). Approximately 0.15 g or 0.15 ml of the investigational product will be applied to the skin of human subjects which will then be exposed to UV radiation an a erythema and dermal response scoring system will be used to evaluate the phototoxic response of the irradiated area within the treated test site of each subject. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunscreen oil with 6% BemotrizinolAlso: PARSOL® SHIELD, SU E 101413 85Sunscreen oil with 6% BEMT (PARSOL® Shield) and 10% ethanol as penetration enhancer | Drug | Phototoxicity evaluation of sunscreen oil with 6% BEMT (SU E 101413 85) |
| Sunscreen oil vehicleAlso: SU E 101413 91Sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT (BEMT replaced by Isopropylmyristate) | Other | Phototoxicity evaluation of sunscreen oil vehicle (SU E 101413 91) |
| Dispersion of 6% BEMT in petrolatumAlso: PARSOL® SHIELD, SU-E-101413-82Dispersion of 6% BEMT (PARSOL® Shield) in petrolatum | Drug | Phototoxicity evaluation of dispersion of 6% BEMT in petrolatum (SU E 101413 82) |
| Petrolatum vehicleAlso: SU-E-101413-83Petrolatum vehicle | Other | Phototoxicity evaluation of petrolatum vehicle (SU-E-101413-83) |
Primary outcome
Determination of the Photoxicity potential of 6% Bemotrizinol 24 hours post-irradiation
Time frame: Phototoxic response will be checked 24 hours post-irradiation
Phototoxic response 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. Dermal scores will be reported as either Phototoxic or Non-Phototoxic responses and 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
Determination of the Photoxicity potential of 6% Bemotrizinol 48 hours post-irradiation
Time frame: Phototoxic response will be checked 48 hours post-irradiation
Phototoxic response 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. Dermal scores will be reported as either Phototoxic or Non-Phototoxic responses and 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Schutz, PhD study director
dsm-firmenich Switzerland AG
Gladys Osis, MT principal investigator
Eurofins CRL Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunscreen oil with 6% Bemotrizinol and Dispersion of 6% BEMT in petrolatum in people with Phototoxic Response, 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 11 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?
Determination of the Photoxicity potential of 6% Bemotrizinol 24 hours post-irradiation (time frame: Phototoxic response will be checked 24 hours post-irradiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.