CTRI/2025/12/099070Not yet recruitingNot Applicable
A Clinical Study to Evaluate the Skin Sensitization Potential of Phoenix Bathing wipes on Healthy Human Volunteers
Phoenix Innovative Healthcare Manufactures Pvt. Ltd.1 site in 1 country210 target enrollmentStarted: December 25, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 210
- Locations
- 1
Study Overview
Brief Summary
210 human volunteers are selected for the patch test done as per ISO 10993 PART 10 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
1.Bathing Wipes
**Estimated time in study completion:**90-100 days.
· Screening Phase
· Induction Phase (21 DAYS) (24 hours after each patch removal)
· Rest Phase (14 DAYS)
Challenge Phase(5 days) (24 hours after the patch removal, 48 hours after patch removal and 72 hours after the patch removal)
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.
- •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.
Investigators
Dr Robin Chugh
CCFT Laboratories
Study Sites (1)
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