Evaluation of skin sensitization potential of test materials by Human Repeat Insult Patch Test (HRIPT)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. To determine the sensitization potential of test materials.
研究概览
简要总结
HRIPT (Human Repeat Insult Patch Test) using 48 hours repeated occlusive patch is the standard procedure used to diagnose contact allergy resulting from type IV hypersensitivity. This test is based on the principle that an allergic individual would elicit a systemic response with an allergen. Therefore, if the substance is applied to the skin on any part of the body it will result in dermatitis at the site. The patch test is performed by applying allergens (test materials in this case) under occlusion on the skin under standardized conditions with repeated dosing for three weeks and thereafter upon complete resolution of the reaction the test article/ allergen is challenged at the test and naïve site.
There are 5 test materials which are components of a medical device. 0.25 ml of extractants in sterile saline and sterile sesame oil and controls will be loaded in an adhesive bandage with 18mm Finn chambers affixed.
There will be 4 phases: Induction phase, rest period, challenge phase and rechallenge phase. This phase of the study will be conducted over approximately 3.5 weeks and will include 10 multiple, 48 hours (72 hours on weekends) sets of patches at a single site on the upper back. Each patch will be left on for 48hours (window period: +1hour) and then removed by the investigator/designee at the study site. Post patch removal, test sites will be wiped with water and a trained assessor will grade the skin site for skin reactions. The next set of patches will be applied on the same site immediately after skin site assessments are performed. The 10 sets of patches will be numbered P1, P2, P3, P4, P5, P6, P7, P8, P9, and P10.
The rest phase will last approximately 21 days. The challenge phase consists of similar patching procedure for 48 hours of patches 11 and 12. On visit 17, assessment 96 hours post patch removal will be done. Reachallenge phase will be performed in case of ambiguity where patches will be applied and scored 48 hours and 96 hours after patch application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male & female participants in the age group 18 to 65 years (both ages inclusive).
- •Subjects in good health condition as per the health screening criteria with no disease state or physical condition that the Investigator believes could interfere with the interpretation of data.
- •Subjects willing to maintain the patch test in position for the required duration.
- •Subjects willing to come for regular follow-up visits.
- •Subjects with a broad upper back.
- •Subjects ready to follow instructions during the study period.
- •Subjects willing to avoid excessive water contact (like swimming etc.) or activity which causes excessive sweating (like exercise, sauna, etc.) during the course of study.
排除标准
- •Subjects with scars, infections, tattoos or wounds on the study area.
- •Subjects that have a known allergy to cosmetics, fragrances, skin care products, topical drugs, adhesive tapes and/or bandages/Band-aids®, or ingredients as related to the products being evaluated
- •Subjects with any clinically significant systemic or cutaneous disease (at the site of application), which may interfere with study treatment or procedures.
- •Subjects with chronic illness (such as bleeding or clotting disorders, hemophilia) which may influence the outcome of the study (self-declared).
- •Subjects who are immunosuppressed or immunodeficient due to medical condition or medication.
- •Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month)
- •Women who are pregnant, planning to become pregnant during the study, or breast-feeding.
- •Subjects who are on anticoagulant therapy (self-declared).
- •Subjects who are prone to actinic keratosis and keloid scars.
- •Subjects who have participated in a similar study within 1 month prior to the initiation of the study.
- •Subjects having moles or excessive hair on the back which may influence the study results as per the investigator and study coordinator’s decision
- •Subjects affiliated with the Sponsor or lab conducting the study
- •Subjects with abnormal skin pigmentation at the test sites that could interfere with subsequent evaluations of dermal responsiveness.
结局指标
主要结局
1. To determine the sensitization potential of test materials.
时间窗: Induction phase : 10 multiple, 48 hours (72 hours on weekends) sets of patches at a single site on the upper back will be applied on Visits 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12. | Rest phase for 21 days | Challenge phase: Similarly, 2 sets of patches will be applied for 48 hours on Visits 13, 14, 15, 16. | Visit 17- assessment 96 hours after patch removal. | Rechallenge phase: in case of ambiguity on Visits 18, 19, 20, 21.
2. To determine the cumulative irritation potential of the test product by 10 occlusive applications.
时间窗: Induction phase : 10 multiple, 48 hours (72 hours on weekends) sets of patches at a single site on the upper back will be applied on Visits 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12. | Rest phase for 21 days | Challenge phase: Similarly, 2 sets of patches will be applied for 48 hours on Visits 13, 14, 15, 16. | Visit 17- assessment 96 hours after patch removal. | Rechallenge phase: in case of ambiguity on Visits 18, 19, 20, 21.
次要结局
未报告次要终点
研究者
Dr Mukta Sachdev
MS Clinical Research Pvt. Ltd.