CTRI/2025/01/079389CompletedNot Applicable
A Clinical Study to Evaluate the Skin Sensitization potential of Confiance Sunscreen Spf 50 & Above on healthy human subjects
Confiance Life Sciences Pvt Ltd1 site in 1 country200 target enrollmentStarted: February 3, 2025Last 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: Sunscreen spf50 & Above
Study Design
- Study Type
- Observational
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.
- •Phototype 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: 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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