CTRI/2016/06/006992招募中未知
Human Cumulative Irritation Patch Test to evaluate the dermatological safety of test products of Haus Bioceuticals
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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
研究者
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