Evaluation of Topically Applied Bemotrizinol for Human Photoallergic Potential
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Photoallergy potential of a BEMT (6%) formulation based on a dermal scoring system 24 hours post irradiation
研究概览
简要总结
This clinical trial will assess the photoallergic potential of BEMT (6%), compared to a vehicle control and a negative control.
详细描述
The primary endpoint of this clinical trial is to evaluate the potential of Bemotrizinol (6%) to produce a photoallergic response.
The potential of 6% Bemotrizinol to produce a photoallergic response after application to the skin of human subjects followed by exposure to ultraviolet (UV) radiation will be assessed via the evaluation of 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-101413-82) and a dispersion of 6% BEMT in petrolatum (SU-E-101413-82).
Upon enrollment, a site on a subject's lower back, isolated from the actual test site, will be chosen to determine the subject's Minimal Erythema Dose (MED). The MED of each subject is assessed by applying a progressive geometric sequence of UV radiation exposures to five sub-sites, each of which is graduated incrementally by 25% over the previous site. The MED is evaluated 16 to 24 hours after ultraviolet radiation.
Duplicate test sites on the back (each approximately 4 cm2) will be identified. Test material will be applied to designated patches and affixed to both sides of the back. One side will be designated for irradiation, and the other is used as a treated/non-irradiated control. Approximately 0.15 g of each investigational product or vehicle controls will be applied to the fabric portion of separate patches with occlusive strips; an un-dosed patch will also be used.
Approximately 24 hours after application, the patches will be removed and the skin will be gently wiped. The 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. The sites designated for irradiation will be then irradiated with solar simulated light by two times an individual's MED.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
Subjects will be blinded to the name of the investigational products. The Investigatory staff will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
- •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."
排除标准
- •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;
- •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.
研究组 & 干预措施
6% BEMT in sunscreen oil (SU E 101413 85)
Assess the photoallergic potential of Sunscreen oil with 6% BEMT (PARSOL® Shield) and 10% ethanol as penetration enhancer a test material (formulation: SU E 101413 85).
Approximately 0.15 g or 0.15 ml of each product and vehicle control will be applied. Two doses (one irradiated and one non- irradiated) of the investigational products and two doses (one irradiated and one non- irradiated) of the vehicle controls will be applied to back of each subject once on Day 1 under occlusive patches. Patches will remain in place for approximately 24 hours and will be removed by clinical study staff on Day 2. During the challenge phase, two undosed negative control occlusive patches will also be also applied. Subjects will return to the laboratory 24 hours and 48 hours post-irradiation for dermal evaluations. Dermal scores obtained during the challenge phase will be reported for each site.
干预措施: 6% Bemotrizinol in sunscreen formulation (Drug)
Sunscreen oil Vehicle (SU E 101413 91)
Vehicle Control: Assess the photoallergenic potential of sunscreen oil vehicle with 10% ethanol as penetration enhancer without BEMT.
Approximately 0.15 g or 0.15 ml of each product and vehicle control will be applied. Two doses (one irradiated and one non- irradiated) of the investigational products and two doses (one irradiated and one non- irradiated) of the vehicle controls will be applied to back of each subject once on Day 1 under occlusive patches. Patches will remain in place for approximately 24 hours and will be removed by clinical study staff on Day 2. During the challenge phase, two undosed negative control occlusive patches will also be also applied. Subjects will return to the laboratory 24 hours and 48 hours post-irradiation for dermal evaluations. Dermal scores obtained during the challenge phase will be reported for each site.
干预措施: Vehicle (Other)
6% BEMT in petrolatum (SU E 101413 82)
Assess the photoallergenic potential of a dispersion of 6% BEMT (PARSOL® Shield) in petrolatum
Approximately 0.15 g or 0.15 ml of each product and vehicle control will be applied. Two doses (one irradiated and one non- irradiated) of the investigational products and two doses (one irradiated and one non- irradiated) of the vehicle controls will be applied to back of each subject once on Day 1 under occlusive patches. Patches will remain in place for approximately 24 hours and will be removed by clinical study staff on Day 2. During the challenge phase, two undosed negative control occlusive patches will also be also applied. Subjects will return to the laboratory 24 hours and 48 hours post-irradiation for dermal evaluations. Dermal scores obtained during the challenge phase will be reported for each site.
干预措施: 6% Bemotrizinol in petrolatum (Drug)
结局指标
主要结局
Photoallergy potential of a BEMT (6%) formulation based on a dermal scoring system 24 hours post irradiation
时间窗: Photoallergy response will be evaluated 24 hours post irradiation
Photoallergenicity conclusions (i.e., "Photoallergic Response" or "Not a contact sensitizer or photoallergen") will 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. 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
Photoallergy potential of a BEMT (6%) formulation based on a dermal scoring system 48 hours post irradiation
时间窗: Photoallergy response will be evaluated at 48 hours post irradiation
Photoallergenicity conclusions (i.e., "Photoallergic Response" or "Not a contact sensitizer or photoallergen") will 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. 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
Photoallergy potential of a BEMT (6%) formulation based on a dermal scoring system 72 hours post irradiation
时间窗: Photoallergy response will be evaluated at 72 hours post irradiation
Photoallergenicity conclusions (i.e., "Photoallergic Response" or "Not a contact sensitizer or photoallergen") will 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. 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
次要结局
未报告次要终点