CTRI/2024/01/061543CompletedUnknown
A Clinical Study to evaluate the skin irritation potential of Fifth sense naturals, Maate Kids Conditioner and Maate Baby Wipes on healthy human subjects.
Fifth sense Naturals pvt Ltd1 site in 1 country24 target enrollmentStarted: January 20, 2024Last updated:
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change in Skin Irritation Score-erythema & oedema
Study Overview
Brief Summary
The below products would be tested as per the guideline IS4011 for dermal safety assessment.
- Maate Kids Conditioner
2.Maate Baby Vibes
The product will be tested for skin irritation on 24 human volunteers for 24 hours.
Assessment would be done on day 0, day 1, with follow up visit on day 8 for erythema and Oedema scoring.
Study is done as per BIS standard 4011
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Voluntary man or women between 18 and 65 years.
- •Photo type III to V.
- •Having apparently healthy skin on test area
- •For whom the investigator considers that the compliance will be correct.
- •Cooperating informed of the need and duration of the examinations and ready to comply with protocol procedures.
- •Having signed a Consent Form.
- •Willingness to avoid intense UV exposure on test site (sun or artificial UV) during the course of the study.
- •Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna) during the course of the study.
- •Should be able to read and write (in English, Hindi or local language).
- •Having valid proof of identity and age.
Exclusion Criteria
- •Pregnant or nursing mothers 2.Scars, excessive terminal hair or tattoo on the studied area.
- •3.Henna tattoo anywhere on the body (in case of studies involving hair dyes).
- •4.Dermatological infection or pathology on the level of studied area.
- •5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
- •6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
- •7.Chronic illness which may influence the outcome of the study.
- •8.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •9.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial.
Outcomes
Primary Outcomes
Change in Skin Irritation Score-erythema & oedema
Time Frame: Day 0, Day 2 and Day 8
Secondary Outcomes
- Not Applicable(Not Applicable)
Investigators
Dr Sanjay Gupta
CCFT Laboratories
Study Sites (1)
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