CTRI/2023/01/048870Completed未知
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion | Semi Occlusion |Open Patch on Adult Healthy Human Subjects
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Enrollment
- 25
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 number of males and females).
- •3. Subject with normal Fitzpatrick skin type III to V (Human skin colour determination scale).
- •4. Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
- •5. Subject who do not have any previous history of adverse skin conditions and are not under any medication likely to interfere with the results.
- •6. The subject is in good general health as determined by the Investigator on the basis of medical history.
- •7. Subjects are willing to maintain the test patches in designated positions for 24 Hours.
- •8. Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- •9. The subject must be able to understand and provide written informed consent to participate in the study.
- •10. Subject is willing to refrain from vigorous physical exercise during the study period and follow all the instructions given.
Exclusion Criteria
- •1. Subject 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. Subject having history of diabetes
- •4. Subject 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. Subject suffering from any active clinically significant skin diseases which may contraindicate.
- •6. Subject 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. Subject having history of asthma or COPD (Chronic obstructive pulmonary disease).
- •9. 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)
- •10. Topical drugs used at application site.
- •11. Subject with Self-reported Immunological disorders such as HIV positive, AIDS and/or systemic lupus erythematous.
- •12. 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.
- •13. Subject with known allergy or sensitization to medical adhesives, bandages.
- •14. Participation in other patch study simultaneously.
Investigators
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