CTRI/2019/07/019999已完成不适用
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
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Dermatological assessment of cutaneous Irritation (i.e. redness, dryness, burning, itching and stinging) on chest, back and throat using 5 point scale by Dermatologist as compared from baseline i.e. Day 00 before application to 30 min after application on Day 00 and on Day 15 of test product use.
研究概览
简要总结
Anopen-label, non-comparative, safety in use tolerance study to evaluate thesafety of Mentholated Topical Ointment by repeat use test (14 consecutive days)in healthy Children and Adult human subjects. Total study duration is 15 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: For adult 18 to 65 years (both inclusive) and for children 6 to 12 years (both inclusive) old at the time of consent.
- •Sex: For adult, Healthy male and Non-pregnant/non-lactating females, For Children, Healthy Male and female’s child.
- •Females of childbearing potential and menarche children both must have a negative urine pregnancy test performed on screening visit.
- •Subjects are in good general health as determined by the Investigator on the basis of medical history reported by subjects and subject’s Parent/legal guardian/caregiver.
- •Adult subjects must be able to understand and provide written informed consent to participate in the study.
- •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.
- •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.
- •Should be current users of skin ointment/skin balm, e.g. Vicks VapoRub, Zandu Balm, and Tiger Balm, Amrutanjan or similar product.
- •Subject’s participating parent/legal guardian/caregiver must be able to provide government authorized legal proof of child’s to participate in the study.
- •Subjects and subject’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
- •Pregnant or lactating female subjects should be excluded as these conditions impact the condition of the skin.
- •Subjects who have a clinically significant active dermatitis or skin disease anywhere on the body (excluding facial acne).
- •Subjects who have a history of psoriasis, eczema or skin cancer.
- •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.
- •Subjects who have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months.
- •Subjects who have history of a mastectomy or axillary lymph nodes removed.
- •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.
- •Subjects who have history of insulin-dependent diabetes.
- •Subjects who have history of asthma or any other chronic respiratory condition requiring daily therapy.
- •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.
- •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.
- •Subjects who are currently participating in any another dermal study.
- •Subjects who are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study.
- •Subjects who have a known sensitivity or allergy relating to the substance(s) being evaluated.
结局指标
主要结局
Dermatological assessment of cutaneous Irritation (i.e. redness, dryness, burning, itching and stinging) on chest, back and throat using 5 point scale by Dermatologist as compared from baseline i.e. Day 00 before application to 30 min after application on Day 00 and on Day 15 of test product use.
时间窗: Baseline i.e. 30 minutes before application on Day 00 and after 30 minutes on Day 15 of test product use.
次要结局
- To evaluate subject self-assessment questionnaires will be done by subjects in their local language at baseline i.e. before application on Day 00 and on Day 15 of test product use.(baseline i.e. 30 minutes before application on Day 00 and after 30 minutes on Day 15 of test product use.)
研究者
研究点 (1)
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