Human Repeat Insult Patch Test to evaluate the dermatological safety of test products of Haus Bioceuticals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- To evaluate the dermatological safety of test product by human repeated insult patch test
研究概览
简要总结
Study Objective:The purpose of this study is to confirm that the test substances will not produce evidence of delayed contact sensitization following external contact with the skin by means of a repeated patch application procedure.
Sample Size: N=116 comprising of three subsets of population:
- n1 = 100 normal subjects - n2 = 06 subjects diagnosed with atopic dermatitis - n3 = 10 subjects diagnosed with plaque psoriasis
Study Duration : Approximately 6 Weeks for each subject.
Total No. of visits : 15 Visits
During Induction phase- 3 weeks All the test products will be applied every alternate day for three weeks for a total of 9 patch applications. Each application will be for 48 hours under occlusion (complete or semi based on product type).Evaluation of irritation will be done before application of succeeding patch.
This will followed by a rest phase of approximately of 2 weeks
During challenge phase, the patches will beapplied to the original site (initial induction site) and, a similar untested/naïve site, preferable on the opposite side of the body (alternate site). Patches are worn for 48 hours (± 1 hour), then removed at the site and discarded. Readings are taken at 48, 72 and 96 hrs after removal
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •In order to be eligible for participation, subjects must be: 1.males or females 18 years of age or older – 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.
结局指标
主要结局
To evaluate the dermatological safety of test product by human repeated insult patch test
时间窗: Approximately 6 weeks for each subjects
次要结局
未报告次要终点