CTRI/2019/04/018851已完成未知
7 day human cumulative irritation patch test
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 40
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 and non-pregnant/non-lactating females between the ages of 18 and 65 at the time of consent.
- •2. Females of childbearing potential must have a negative urine pregnancy test performed on Day 1 prior to patch application.
- •3. In general good health as determined by the Medical and Dermatological History Questionnaire (Appendix A).
- •4. Able to read, understand and sign an informed consent agreement after being advised of the nature of the study.
- •5. 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.
- •6. Willing to refrain from exposing skin sites to the sun or going to tanning beds for the duration of the study.
- •7. Willing to refrain from swimming and using hot tubs for the duration of the study.
排除标准
- •1. Have a clinically significant active dermatitis or skin disease anywhere on the body (excluding facial acne).
- •2. Have a history of psoriasis, eczema or skin cancer.
- •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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