CTRI/2019/07/020072CompletedNot Applicable
Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types.
ITC Life Sciences and Technology Centre1 site in 1 country24 target enrollmentStarted: July 15, 2019Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Safety assessment of products
Study Overview
Brief Summary
The objective of this study is to evaluate thedermatological safety of the investigational products on healthy human subjectswith adequate representation of varied skin types (Oily, Dry, Normal andCombination).
Evaluation of dermatological safety of products by primary irritation patch test on healthy human volunteers of varied skin types. Test products will be tested against controls involving 24 subjects. Total study duration is 10 days.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Healthy male and female subjects in the age group of 18-55 years (both age inclusive).
- •2.Subjects with Fitzpatrick skin type III to V.
- •3.Subjects with good general health as determined by the Investigator on the basis of medical history.
- •4.Subjects willing to give a voluntary written informed consent.
- •6.Subjects having not participated in a similar investigation in the past two weeks.
- •7.Subjects willing to come for regular follow up visits.
- •9.Subjects without any open wounds, cuts, abrasions, irritation symptoms.
Exclusion Criteria
- •1.Female subject is pregnant, planning for pregnancy, or lactating.
- •2.Subject having skin irritation, pigmentation, pimple, excessive hair, mole, blemishes, marks (e.g. tattoos, scars, sunburn), or any dermatological condition that can interfere with the reading on test sites.
- •3.Medication which may affect skin response and/or past medical history.
- •4.Subject having history of diabetes.
- •5.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.
- •6.Subject suffering from any active clinically significant skin diseases which may contraindicate.
- •8.Participation in any patch test for irritation or sensitization within the last four weeks.
- •9.Subject having history of Bronchial Asthma.
- •10.Subject with Self-reported Immunological disorders such as HIV, AIDS and systemic lupus erythematous.
- •11.Individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
- •12.Subject with known allergy or sensitization to medical adhesives, bandages.
- •13.Participation in other patch study simultaneously.
- •14.Use of any: a.Prescribed or over-the-counter (OTC) anti-inflammatory drug within five (5) days prior to enrolment in the current study.
- •b.Antihistamine medication or immunosuppressive drugs within seven (7) days prior to first patch application.
- •c.Systemic or topical corticosteroids at patch site within four (4) weeks of investigational product application (steroids nose drops and/or eye drops are permitted) d.Topical drugs used at application site.
Outcomes
Primary Outcomes
Safety assessment of products
Time Frame: Baseline, 0 hour, 24 hours and 07 Days
Secondary Outcomes
- Not Applicable(Not Applicable)
Investigators
Study Sites (1)
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