CTRI/2023/06/054003已完成不适用
To evaluate the dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of with sensitive skin
ITC LIMITED ITC Life Sciences and Technology Centre1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年1月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Dermatological safety / Irritation potential on skin
研究概览
简要总结
Single Application, Closed & Occlusive Patch Test isconducted to measure the irritation potential of cosmetic products on the skin.
Objective: Toevaluate the dermatological safety of investigational products through primaryirritation patch test on healthy human volunteers with sensitive skin.
Duration of study: 8 days study Kinetics: T0 (Evaluation oftest sites by Dermat and Subject, Patch application), T on patch ApplicationDay, T+30mins post patch application, T1(Patch removal, Evaluation of testsites by Dermat), T2(Evaluation of test sites by Dermat and Subject post 24 hrsof patch removal), T8 (Evaluation of test sites by Dermat and Subject post 1week of patch removal and tracking the positive cases)
Population 35 healthy subjects(17 males + 18 females)
The distribution of volunteers as per skin type will be asfollows: Sensitive Combination skin : 4 Females + 4 Males Sensitive Dry skin –4 Females + 4 Males Sensitive Oily skin – 5 Females + 5 Males Sensitive Normalskin – 4/5 Females + 4/5 Males
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
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.Female and male Asian Indian subjects.
- •2.Healthy human subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory checkup).
- •3.Between 18 and 65 years of age.
- •4.Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….).
- •5.Specific Criteria -Subjects representing sensitive skin type (Subjects scoring greater than 30 for Section 2- Sensitive vs Resistant skin in Dr. Baumann’s questionnaire, please refer appendix 4) and varied skin type (ideally equal representation of all 4 skin types – Oily, Normal, Dry and Combination).
- •Subjects who have not participated in a similar investigation in the past eight weeks.
排除标准
- •1.Standard criteria -For female: Currently established to be pregnant or actively breast feeding or has recently stopped breast feeding < 3 months. -Having refused to give his/her assent by signing the consent form.
- •Currently participating in another study that is liable to interfere with this study. -Being diabetic. -Being asthmatic. -Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •Subjects with chronic illness that may influence the cutaneous state or any other illness including Diabetes, liver disease, HIV or any other serious medical illness. -Subjects with cutaneous disease that could interfere with the study results. -Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products. -Having undergone surgery requiring general anesthesia of more than one hour in the past 6 months. -Having changed his/her cosmetic habits in the 14 days preceding the start of the study on the studied anatomic unit. -Having applied some product on the back thus not meeting the study requirement. -No individual sentenced to imprisonment by a court decision or by an administrative decision, or hospitalized without consent, or admitted in a medical or social establishment.
- •No minor as well as individual of age benefiting from a legal protection measure or enable to express his/her consent 2.Refusing to follow the restrictions mentioned below during the study:.
- •For female: Avoid pregnancy or active breastfeeding.
- •Abstain from participation in another study liable to interfere with this study.
- •Do not take medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, antihistamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol).
- •Do not change cosmetic habits apart from the particular conditions mentioned in the protocol, on the studied anatomic unit. 3.Specific criteria.
- •Having eczema, psoriasis, lichen planus, vitiligo etc. in the concerned area. -Having healing disorder in the concerned area. -Having rhinitis, allergic conjunctivitis, or rhino sinusitis. -Having an allergy to perfumes and/or preservatives in cosmetic products. -Having an allergy to plaster / adhesives used in plaster.
- •Having a food allergy. -Having a cardiovascular pathology that requires beta blocking treatments. -Having immunosuppressive drugs, such as cyclophosphamide, methotrexate, azathioprine, etc. -Taking a retinoid-based treatment by general or oral route. -Taking specific treatment on the back.
- •Having taken an anti-histaminic treatment in the last 2 weeks preceding the start of the study. – Having miliaria (prickly heat) on the back.
- •Presenting too many neavi on the back.
- •Having high pilosity on the back.
- •Refusing to follow the restrictions below during the study:.
- •During the first 24 hours (after patch application), neither cosmetic products nor water must be applied on the back.
- •Till the follow up period of until T8 days, only water is accepted from the first reading i.e., T2 days (Evaluation of test sites by Dermat and Subject post 24 hrs. of patch removal).
- •Do not practice an intensive sport activity during the first 24 hours (until the removal of the patches).
- •Do not expose the back to the sun.
结局指标
主要结局
Dermatological safety / Irritation potential on skin
时间窗: Baseline,0 hrs,24 hrs & 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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