To assess the skin irritation and sensitization potential of the 3 Investigational products by repeated application of occlusive patches.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Trained evaluator assessment of product tolerability through Draize scale (Dermal response) on D2, D4, D6, D8, D10, D12, D14, D16, D18 and D35, D36, D37
研究概览
简要总结
| An evaluator (single) blind, test site randomized and intra-subject comparison of repeated insult patch test study to evaluate the cutaneous irritation potential of three experimental investigational products, including a control. |
Following provision of informed consent and completion of all screening assessments, eligible subjects will be enrolled in the study.
Study is conducted over a period of 37 days for each subject. Products will be evaluated through repeated application via occlusive patches onto the dorsum scapular region skin of healthy males & behind upper left arm for healthy females for a 24-hour period on D1, D3, D5, D7, D9, D11, D13, D15, D17& post patch removal evaluation shall be done by Principal investigator for grading.
Patches will be removed after 24 hours and the skin will be assessed for any signs of irritation on D2, D4, D6, D8, D10, D12, D14, D16, D18, this phase of the study is called as Induction Phase.
From D19 till D32- resting Phase will be there where in no study activities shall be performed, this will be wash out period. From D33 till D36 Challenge phase will be there, where in subjects will be applied Patch on D33, removal shall be done after 24 hours, Dermatologic evaluation will be done 24 hours post patch removal, then post 48 hours, & lastly post 72 hours.
Assessments
Subjects will undergo visual evaluations of dermal irritancy performed by a trained assessor on D2, D4, D6, D8, D10, D12, D14, D16, D18 in induction phase. Once again visual evaluations of dermal irritancy performed by a trained assessor on D35, D36, D37 in Challenge phase.
The Draize scores will be analyzed to establish the irritation potential of each test product in Induction phase. While in Challenge phase ICDRG scale will be used to see the irritation potential of each test product.
Subjects will be assessed for frequency and severity of adverse events.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female volunteers aged 18 to 65 with no active dermatological conditions 2.Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination 3.Subjects who have intact skin on the proposed application site; dorsum (scapular region) 4.Fitzpatrick photo type I to IV skin type 5.Willingness to participate as evidenced by voluntary written informed consent.
排除标准
- •Exclusion Criteria: 1.Women who are known to be pregnant or who are intending to become pregnant over the duration of the study 2.Women who are breast-feeding 3.Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
- •4.Presence of open sores, pimples, or cysts at the application site.
- •5.Active dermatosis (local or disseminated) that might interfere with the results of the study.
- •6.Considered immune compromised.
- •7.History of diseases aggravated or triggered by ultraviolet radiation.
- •8.Participants with dermatographism.
- •9.Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
- •10.Use of the following topical or systemic medications: immunosuppressants, antihistamines, nonhormonal anti-inflammatory drugs, and corticosteroids up to 2 weeks before screening visit.
- •11.Oral or topical treatment with vitamin A acid and/or its derivatives up to 1 month before the screening visit 12.Intention of being vaccinated during the study period or vaccination within 3 weeks of the screening visit.
- •13.Currently receiving allergy injections, or due to receive an injection within 7 days prior to Visit1, or expects to begin injections during study participation 14.Previous history of atop, allergic reactions, irritation or intense discomfort feelings to topical use products, cosmetics, or medication 15.Known or suspected intolerance or hypersensitivity to any of the study materials (or closely related compounds) or any of their stated ingredient including any component of the patches 16.History of sensitization in a previous patch study 17.Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30days of the screening visit 18.Recent history (within the last years) of alcohol or other substance abuse.
结局指标
主要结局
Trained evaluator assessment of product tolerability through Draize scale (Dermal response) on D2, D4, D6, D8, D10, D12, D14, D16, D18 and D35, D36, D37
时间窗: Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18 and Day 35, Day 36, Day 37
次要结局
- Frequency and severity of Adverse Events(Day 2, Day 4, Day 6, Day 8, Day 10, Day 12, Day 14, Day 16, Day 18 and Day 35, Day 36, Day 37)