Clinical Evaluation of the Allergenic Potential of a Cosmetic Product Using the Human Repeat Insult Patch Test (HRIPT) and Phototest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Dermal Irritation Assessed by Human Repeat Insult Patch Test (HRIPT) Using ICDRG Criteria
研究概览
简要总结
This clinical study will evaluate the dermatological safety and allergenic potential of a cosmetic product. The study will use the Human Repeat Insult Patch Test (HRIPT) and phototest procedures to assess whether the product may cause skin irritation, allergic reactions, photoirritation, or photosensitization after repeated use and exposure to ultraviolet light.
Participants will receive applications of the investigational product under controlled conditions and will undergo dermatological evaluations throughout the study. The results will help determine the product's skin compatibility and safety for consumer use.
详细描述
This is a single-center, single-blind, non-comparative clinical study designed to evaluate the dermal compatibility and allergenic potential of an investigational cosmetic product using the Human Repeat Insult Patch Test (HRIPT) and phototest procedures.
The HRIPT phase will assess primary dermal irritation, cumulative irritation, and skin sensitization potential through repeated applications of patches containing the investigational product to the participants' backs under maximized conditions. The practical phase lasts six weeks and includes three weeks of product application, two weeks of rest, and one challenge week with product reapplication on a previously untreated skin site.
The phototest phase will assess the photoirritant and photosensitizing potential of the investigational product following controlled exposure to ultraviolet radiation. Product-containing patches will be applied to the skin and, after removal, the test sites will undergo controlled ultraviolet irradiation. The practical phase lasts five weeks and includes induction, rest, and challenge phases.
Dermatological evaluations will be performed according to standardized criteria, including assessments based on the International Contact Dermatitis Research Group (ICDRG) scale, to confirm the absence of clinically significant irritant, allergenic, photoirritant, or photosensitizing reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants are blinded to the identity, brand name, and commercial information of the study product. The product is applied without disclosure of its name or manufacturer to the participants.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants aged 18 to 70 years.
- •Fitzpatrick skin phototypes I, II, III, or IV.
- •Intact skin at the application site.
- •Willingness to comply with all study procedures and attend scheduled clinic visits for medical assessments, patch applications, and patch readings.
- •Ability to understand the study requirements, provide written informed consent, and sign the Informed Consent Form (ICF).
- •For the phototest procedure, only participants with Fitzpatrick skin phototypes II and III will be eligible.
排除标准
- •Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study.
- •Use of anti-inflammatory medications within 30 days prior to screening or immunosuppressive medications within 3 months prior to screening.
- •Immunosuppression due to medication use or active disease.
- •Uncontrolled endocrine disorders.
- •Personal history of atopy.
- •Intense sun exposure or tanning sessions within 15 days prior to assessment or during the study period.
- •Planned intense sun exposure or tanning sessions during the study period.
- •Planned sea bathing, swimming pool use, or sauna sessions during the study period.
- •Participation in water sports during the study period.
- •Dermographism.
- •Use of oral or topical vitamin A acid (retinoids) or related derivatives within 1 week prior to study initiation.
- •Aesthetic and/or dermatological body treatments within 3 weeks prior to screening.
- •Scheduled vaccination during the study period or within 3 weeks prior to screening.
- •History of sensitization, irritation, or photosensitization to topical products.
- •Active local or generalized skin diseases that may interfere with study assessments.
- •Skin hyperreactivity.
- •Initiation of new medications during the study period.
- •Previous participation in studies involving the same investigational product.
- •Congenital or acquired immunodeficiency.
- •Relevant medical history or current evidence of alcohol or substance abuse.
- •Known or suspected intolerance to any ingredient contained in the investigational or comparator products.
- •History of poor compliance or unwillingness to comply with the study protocol.
- •Employees of the study site, sponsor, or their immediate family members directly involved in the study.
- •Any other condition that, in the investigator's opinion, may interfere with study participation or justify exclusion from the study.
- •Additional Exclusion Criteria for the Phototest:
- •History of diseases aggravated or triggered by ultraviolet radiation.
- •Use of photosensitizing medications.
- •History or current presence of photodermatoses.
- •Personal or family history of skin cancer.
- •Presence of precancerous skin lesions, including melanocytic nevi or actinic keratoses, that may interfere with study assessments.
研究组 & 干预措施
Investigational Cosmetic Product
Participants will undergo Human Repeat Insult Patch Test (HRIPT) and phototest procedures using the investigational cosmetic product to evaluate dermatological safety, skin irritation, skin sensitization, photoirritation, and photosensitization potential.
干预措施: Blancy Pro (Other)
结局指标
主要结局
Dermal Irritation Assessed by Human Repeat Insult Patch Test (HRIPT) Using ICDRG Criteria
时间窗: Day 3 and Day 5
Dermal irritation following application of Blancy Pro will be assessed using the Human Repeat Insult Patch Test (HRIPT). Patches containing the investigational product and control patches (saline solution, mineral oil, patch without product, and adhesive tape control) will be applied to the lateral back. Skin reactions will be evaluated 48 hours (Day 3) and 96 hours (Day 5) after application according to the International Contact Dermatitis Research Group (ICDRG) grading scale. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Cumulative Dermal Irritation Assessed by Human Repeat Insult Patch Test (HRIPT) Using ICDRG Criteria
时间窗: Day 3, Day 5, Day 8, Day 10, Day 12, Day 15, Day 17, and Day 19
Cumulative dermal irritation following repeated applications of Blancy Pro will be assessed using the Human Repeat Insult Patch Test (HRIPT). Patches containing the investigational product and control materials will be repeatedly applied to the lateral back over a 3-week induction period. Skin reactions will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Dermal Sensitization Assessed by Human Repeat Insult Patch Test (HRIPT) Challenge Phase Using ICDRG Criteria
时间窗: Day 38 and Day 39
Dermal sensitization following repeated application of Blancy Pro will be assessed during the Human Repeat Insult Patch Test (HRIPT) challenge phase. After a two-week rest period, patches containing the investigational product and control materials will be applied to previously unexposed skin sites. Skin reactions will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Dermal Photoirritation Assessed by Phototest Using ICDRG Criteria
时间窗: Day 2 and Day 4
Dermal photoirritation following application of Blancy Pro will be assessed using phototest procedures. Patches containing the investigational product and control materials (saline solution, mineral oil, patch without product, and adhesive tape control) will be applied to the medial back. After 24 hours, patches will be removed, skin reactions will be assessed, and the test sites will be exposed to ultraviolet A (UVA) radiation at a dose of 5 J/cm². Additional assessments will be performed 48 hours after irradiation according to the International Contact Dermatitis Research Group (ICDRG) grading criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Dermal Photosensitization Assessed by Phototest Induction Phase Using ICDRG Criteria
时间窗: Day 2, Day 4, Day 5, Day 8, Day 10, and Day 12
Dermal photosensitization following repeated application of Blancy Pro and controlled ultraviolet A (UVA) exposure will be assessed during the phototest induction phase. Patches containing the investigational product and control materials will be applied to the medial back and irradiated with UVA at a dose of 5 J/cm². Skin reactions will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
Dermal Photosensitization Assessed by Phototest Challenge Phase Using ICDRG Criteria
时间窗: Day 30 and Day 32
Dermal photosensitization following repeated application of Blancy Pro will be assessed during the phototest challenge phase. After a two-week rest period, patches containing the investigational product and control materials will be applied to two previously unexposed skin sites. One test area will be irradiated with ultraviolet A (UVA) radiation at a dose of 5 J/cm². Skin reactions in both test areas will be evaluated 15 to 30 minutes after patch removal and graded according to the International Contact Dermatitis Research Group (ICDRG) criteria. Skin reactions will be graded according to the International Contact Dermatitis Research Group (ICDRG) criteria, ranging from 0 (negative reaction) to 4 (strong positive reaction). Higher grades indicate greater skin reactivity.
次要结局
未报告次要终点