CTRI/2019/04/018851已完成不适用
7 day human cumulative irritation patch test
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety assessment of products
研究概览
简要总结
7 Daycumulative irritation patch testing performed to know potential of testsubstances to elicit human skin irritation by repetitive topical application upto 7 days. Total study duration is 08 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor 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
- •Males and non-pregnant/non-lactating females between the ages of 18 and 65 at the time of consent.
- •Females of childbearing potential must have a negative urine pregnancy test performed on Day 1 prior to patch application.
- •In general good health as determined by the Medical and Dermatological History Questionnaire (Appendix A).
- •Able to read, understand and sign an informed consent agreement after being advised of the nature of the study.
- •Willing to refrain from using lotions, creams, powders or other skin preparations on the skin in the test area for the duration of the study.
- •Willing to refrain from swimming and using hot tubs for the duration of the study.
排除标准
- •Have a clinically significant active dermatitis or skin disease anywhere on the body (excluding facial acne).
- •Have a history of psoriasis, eczema or skin cancer.
- •Have a condition or are taking medication(s) which, in the judgment of the Investigator or Designate, makes the subject ineligible or places the subject at undue risk.
- •Have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months.
- •Have had a mastectomy or axillary lymph nodes removed.
- •Have an autoimmune or immune deficiency disease (e.g. lupus, myositis, Crohns disease, autoimmune thyroid diseases, autoimmune hepatitis, etc.).
- •Have insulin-dependent diabetes.
- •Have asthma or any other chronic respiratory condition requiring daily therapy.
- •Are currently taking/using any antihistamines or systemic/topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.) on a routine or frequent basis.
- •Maximum acceptable dosage should be determined by written laboratory guidelines.
- •Are currently receiving allergy injections, expects to start injections before the conclusion of the study or has had the final injection within a week of the study start.
- •Are currently participating in another dermal study of any kind.
- •Are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study.
- •Have a confirmed skin allergy as a result of participation in a patch study.
- •Have a known sensitivity or allergy to adhesives, surgical tapes, bandages, etc.
- •Have scars, moles, sunburn, tattoos, etc.
- •in the patch area.
结局指标
主要结局
Safety assessment of products
时间窗: 20 - 40 minutes Irritation Scoring post patch removal Day 02, Day 03, Day 04, Day 05, Day 06, Day 07 and Day 08
次要结局
- Not Applicable(Not Applicable)
研究者
研究点 (1)
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