CTRI/2024/04/066512Not yet recruitingNot Applicable
A Clinical Study to evaluate the skin irritation potential of Green Dream Bharat Pankhudiyan Holi colors on healthy human subjects
Green Dream Bharat1 site in 1 country24 target enrollmentStarted: May 10, 2024Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change in Skin Irritation Score-erythema & oedema
Study Overview
Brief Summary
The below product would be tested as per the guideline IS4011 for dermal safety assessme****nt.
- PANKHUDIYAN HOLI COLOUR-PINK
2. PANKHUDIYAN HOLI COLOUR-YELLOW
3. PANKHUDIYAN HOLI COLOUR-GREEN
4. PANKHUDIYAN HOLI COLOUR-BLUE
The product will be tested for skin irritation on 24 human volunteers.
Assessment would be done on day 0, day 1, with followup visit on day 7 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
- •1.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 1 and Day 7
Secondary Outcomes
- Not Applicable(Not Applicable)
Investigators
Dr Robin Chugh
CCFT Laboratories
Study Sites (1)
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