CTRI/2019/07/019999
Completed
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.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Procter Gamble Company
- Enrollment
- 120
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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