CTRI/2019/07/019999已完成未知
Safety in use study to assess the cutaneous tolerance of mentholated topical ointment in healthy children and adult human subjects under normal conditions of use.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 120
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. Age: For adult 18 to 65 years (both inclusive) and for children 6 to 12 years (both inclusive) old at the time of consent.
- •2. Sex: For adult, Healthy male and Non-pregnant/non-lactating females, For Children, Healthy Male and femaleâ??s child.
- •3. Females of childbearing potential and menarche children both must have a negative urine pregnancy test performed on screening visit.
- •4. Subjects are in good general health as determined by the Investigator on the basis of medical history reported by subjects and subjectâ??s Parent/legal guardian/caregiver.
- •5. Adult subjects must be able to understand and provide written informed consent to participate in the study.
- •6. Written informed consent from the Parent/legal guardian/caregiver and verbal/oral assent from children between 6 to 12 years of age in the presence of their parent/legal guardian/caregiver.
- •7. No moisturizers, oil, cream, any other ointment or perfume can be used in the chest, neck or back area for the duration of the study; however, subjects may use their normal product(s) for washing their hair, hands and face.
- •8. Should be current users of skin ointment/skin balm, e.g. Vicks VapoRub, Zandu Balm, and Tiger Balm, Amrutanjan or similar product.
- •9. Subjectâ??s participating parent/legal guardian/caregiver must be able to provide government authorized legal proof of childâ??s to participate in the study.
- •10. Subjects and subjectâ??s participating parent/ legal guardian/caregiver should be willing and able to follow the study directions to participate in the study.
排除标准
- •1. Pregnant or lactating female subjects should be excluded as these conditions impact the condition of the skin.
- •2. Subjects who have a clinically significant active dermatitis or skin disease anywhere on the body (excluding facial acne).
- •3. Subjects who have a history of psoriasis, eczema or skin cancer.
- •4. Subjects who 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.
- •5. Subjects who have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months.
- •6. Subjects who have history of a mastectomy or axillary lymph nodes removed.
- •7. Subjects who have history of an autoimmune or immune deficiency disease (e.g. lupus, myositis, Crohns disease, autoimmune thyroid diseases, autoimmune hepatitis, etc.).
- •8.Subjects who are currently taking any immunosuppressant medication.
- •9. Subjects who have history of insulin-dependent diabetes.
- •10. Subjects who have history of asthma or any other chronic respiratory condition requiring daily therapy.
- •11. Subjects who are currently taking/using any antihistamines or systemic/topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.) on a routine or frequent basis.
- •12. Subjects who 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. Subjects who are currently participating in any another dermal study.
- •14. Subjects who are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study.
- •15. Subjects who have a known sensitivity or allergy relating to the substance(s) being evaluated.
研究者
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