CTRI/2024/11/076746CompletedNot Applicable
A Clinical Study to Evaluate the Skin Sensitization potential of Jeena Sikho Shuddhi Dr. Hair oil on healthy human subjects
Jeena Sikho Lifcare Ltd1 site in 1 country200 target enrollmentStarted: November 25, 2024Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in Skin Irritation Score-erythema & oedema
Study Overview
Brief Summary
200 human volunteers are selected for the patch test done as per BIS 4011 for sensitization.
The experiment is 40 days including
Induction phase: 21 days
Rest Phase: 14 days
Challenge Phase: 5 days.
Guideline Followed: BIS 4011: for skin sensitization
Product Type: Shuddhi Dr. Hair Oil
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/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/nursing mothers
- •Scars, excessive terminal hair or tattoo on the studied area.
- •Henna tattoo anywhere on the body (in case of studies involving hair dyes).
- •Dermatological infection/pathology on the level of studied area.
- •Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye).
- •Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures.
- •Chronic illness which may influence the outcome of the study.
- •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).
- •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: D2, D4, D6, D9, D11, D13, D16, D18, D20, D23, D24, D25
Secondary Outcomes
- Not Applicable(Not Applicable)
Investigators
Dr Robin Chugh
CCFT Laboratories
Study Sites (1)
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