CTRI/2019/09/021426Completed未知
Evaluation of the sensitization potential of test products in healthy adult human subjects by repeat insult patch testing
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- The Himalaya Drug Company
- Enrollment
- 345
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1) Age: 18-65 years (both inclusive) at the time of consent.
- •2) Sex: Males and non-pregnant/non-lactating females (preferably equal numbers of males and females).
- •3) Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
- •4) Subjects who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
- •5) Subjects in good general health as determined by the Investigator on the basis of medical history.
- •6) Subjects willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- •7) Subjects must be able to understand and provide written informed consent to participate in the study.
- •8) Subjects willing to take bath using the same soap/cleansers during the study period.
- •9) Subjects willing to refrain from vigorous physical exercise during the study period.
Exclusion Criteria
- •1) Subjects having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
- •2) Medication which may affect skin response and/or past medical history.
- •3) Subjects having history of diabetes.
- •4) Subjects have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
- •5) Subjects suffering from any active clinically significant skin diseases which may contraindicate.
- •6) Subjects having history of any skin diseases including eczema, atopic dermatitis or active cancer.
- •7) Participation in any patch test for irritation or sensitization within the last four weeks.
- •8) Subjects having history of asthma or COPD (Chronic obstructive pulmonary disease).
- •9) Subjects with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
- •10) Individual who has a medical condition or is taking or has taken a medication which, in the Investigatorâ??s judgment, makes the subject ineligible or places the subject at undue risk.
- •11) Subject with known allergy or sensitization to medical adhesives, bandages.
- •12) Subjects has participation in a clinical drug study or skin irritation/sensitization study during the 30 days preceding the initial patch application in this study.
- •13) Subject reports a history of skin sensitivity to shampoos and detergents or a known hypersensitivity and/or sensitization to medical adhesives.
- •14) Subjects reports use of systemic or topical antihistamines (at any site) or uses of topical drugs at patch site(s) within 72 hours prior to patch application.
- •15) Participation in other patch study simultaneously.
- •16) Use of any:
- •i. Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to application.
- •ii. Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
- •iii. Systemic or topical corticosteroids at patch site within four (4) weeks of Test Product application (steroidal nose drops and/or eye drops are permitted).
- •iv. Topical drugs used at application site.
Investigators
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