CTRI/2016/05/006927已完成未知
Human Repeat Insult Patch Test to evaluate the dermatological safety of test products of Haus Bioceuticals - NI
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 116
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
- •In order to be eligible for participation, subjects must be:
- •1.males or females 18 years of age or older â?? no more than 20% of the panel should be comprised of subjects over the age of 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
排除标准
- •Subjects are not eligible for participation if any one of the following applies:
- •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 pigmentation, extensive scarring, or pigmented lesions in the patch areas, which could interfere with the scoring
- •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 using on a routine or frequent basis antihistamines or any systemic or topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.). 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 or Designate, 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
相似试验
已完成
不适用
Skin sensitivity test to evaluate sensitization of test products.CTRI/2013/02/003371Johnson Johnson110
已完成
不适用
To check is the test product is causing irritation or allergy in men/women after repeated applications of patch.CTRI/2020/09/027828Cipla Ltd55
已完成
不适用
To determine whether the test product is causing irritation or allergy in human participants after repeated applications of patchCTRI/2018/07/014741Amishi Consumer Technologies Private Limited230
已完成
2 期
Modified Human Repeat Insult Patch TestCTRI/2012/10/003053Johnson and Johnson110
已完成
不适用
Skin sensitivity test to evaluate sensitization of test products-Repeat insult patch test.CTRI/2014/01/004295Johnson Johnson210