CTRI/2024/01/061466CompletedNot Applicable
Evaluation of Dermatological Safety of Test Products by 24 Hours Patch Test under Complete Occlusion on Adult Healthy Human Participants with Normal Skin.
Transformative Learning Solutions Pvt Ltd.1 site in 1 country26 target enrollmentStarted: February 2, 2024Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- To evaluate the dermatological safety of the test products by 24 Hours Patch Test Under Complete Occlusion on healthy human participants with normal skin.
Study Overview
Brief Summary
The study consists of single application of sample on the upper back of human participants, under occlusive patch for the duration of 24 hour of exposure. After removal of patches post 24 hr. The assessment of skin reaction needs to be evaluated subjectively using the Draize Scale 24hour removal of patches. Follow up reactions will be done one week thereafter to confirm recovery
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Males and non-pregnant or non-lactating females (preferably equal numbers of males and females) between age group of 18 to 65 years (both inclusive) at the time of consent.
- •Participants with normal Fitzpatrick skin type III to V.
- •(Human skin colour determination scale).
- •Females of childbearing potential must have a negative urine pregnancy test performed on Day 01 prior to patch application.
- •Participants who do not have any previous history of adverse skin conditions and are not under any medication are likely to interfere with the results.
- •Participants are in good general health as determined by the Investigator on the basis of medical history.
- •Participants willing to maintain the test patches in designated positions for 24 Hours and refrain from vigorous physical exercise during the study period.
- •Participants willing and able to follow the study directions to participate in the study, return for all specified visits.
- •Participants must be able to understand and provide written informed consent to participate in the study.
- •Participants having valid proof of identity and age.
Exclusion Criteria
- •Participants having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (example tattoos, scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) that is back that can interfere with the reading.
- •Participant with history of asthma or COPD (Chronic obstructive pulmonary disease), diabetes and mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last six months.
- •Participant suffering from any active clinically significant skin diseases which may affect the study results.
- •Participant having history of any skin diseases including eczema, atopic dermatitis.
- •Participation in any patch test for irritation or sensitization within the last four weeks.
- •Participants taking part in another study liable to interfere with the results of this study.
- •Participants with selfreported Immunological disorders such as HIV positive, AIDS and systemic lupus erythematous.
- •Participants with a medical condition or are taking or have taken a medication which, in the Investigators judgment, makes the Participant ineligible or places the Participant at undue risk.
- •Participant with known allergy or sensitization to medical adhesives bandages.
- •Use of any: a.
- •Antihistamine medication or immunosuppressive drugs within seven days prior to first patch application.
- •Systemic or topical corticosteroids at patch site within four weeks of test product application (steroidal nose drops and or eye drops are permitted) d.
- •Topical drugs used at application site.
Outcomes
Primary Outcomes
To evaluate the dermatological safety of the test products by 24 Hours Patch Test Under Complete Occlusion on healthy human participants with normal skin.
Time Frame: 30 minutes of patch removal (Day 02), 24 hours (Day 03) and 168 hours (Day 09)
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Bhagirath Patel
Cliantha Research
Study Sites (1)
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