CTRI/2016/06/006992招募中不适用
Human Cumulative Irritation Patch Test to evaluate the dermatological safety of test products of Haus Bioceuticals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- To assess the potential of test substances to elicit human skin irritation by repetitive topical application.
研究概览
简要总结
Study Objective:
To assess the potential of test substances to elicit human skin irritation by repetitive topical application.
Study Duration: Approximately 15 days for each subject.
Study Population: Total 46 subjects ( 30 normal healthy subjects, 06 subjects with atopic dermatitis and 10 subjects with active plaque psoriasis.
Methodology:
Patch applications under complete or semi occlusion are made on consecutive days (including Saturday and Sunday) for 14 days for each product. A final grade is taken 24 hours following the last patch application.
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.males or females between the ages of 18 and 65 2.in general good health as determined by the Medical and Dermatological History Questionnaire (Appendix A) or as having diagnosed with atopic dermatitis or active plaque psoriasis confirmed by a dermatologist 3.Able to read, understand and sign an informed consent agreement after being advised of the nature of the study 4.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 5.Willing to refrain from exposing skin sites to the sun or going to tanning beds for the duration of the study 6.Willing to refrain from swimming and using hot tubs for the duration of the study.
排除标准
- •1.have a clinical diagnosis of a dermatological condition other that atopic dermatitis or psoriasis (such as contact dermatitis, cutaneous lymphoma, tinea corporis, etc.), or have nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular), or have bacterial infections of the skin, including impetigo or abscesses.
- •2.have a history of skin cancer or have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months 3.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 4.have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months 5.have had a mastectomy or axillary lymph nodes removed 6.have an autoimmune or immune deficiency disease (e.g. lupus, myositis, Crohns disease, autoimmune thyroid diseases, autoimmune hepatitis, etc.) 7.are currently taking any immunosuppressant medication 8.have insulin-dependent diabetes 9.have asthma or any other chronic respiratory condition requiring daily therapy 10.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.
- •11.have used a topical anti-inflammatory in the patch area within the last 2 weeks 12.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 13.are currently participating in another dermal study of any kind 14.are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study.
- •15.have a confirmed skin allergy as a result of participation in a patch study 16.have a known sensitivity or allergy relating to the substance(s) being evaluated 17.have a known sensitivity or allergy to adhesives, surgical tapes, bandages, etc.
- •18.have scars, moles, sunburn, tattoos, etc.
- •in the patch area.
结局指标
主要结局
To assess the potential of test substances to elicit human skin irritation by repetitive topical application.
时间窗: Approximately 15 days for each subject.
次要结局
未报告次要终点
研究者
研究点 (1)
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