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Clinical Trials/CTRI/2025/02/081158
CTRI/2025/02/081158CompletedNot Applicable

A Clinical Study to Evaluate the Skin Irritation Potential of Yami Ghar URD and Skin Kanti Soap on Healthy Human Volunteers

Ymi Ghar Soaps Pvt. Ltd1 site in 1 country24 target enrollmentStarted: March 4, 2025
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Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
24
Locations
1
Primary Endpoint
Change in Skin Irritation Score-erythema & oedema
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The below products would be tested as per the guideline BIS4011 for dermal safety assessment. 
  1. URD Soap
  2. Skin Kanti Soap

The product will be tested for skin irritation on 24 human volunteers.

Assessment would be done on day 0, day 2, with followup visit on day 8 for erythema and Oedema scoring

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.

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

Sponsor
Ymi Ghar Soaps Pvt. Ltd
Sponsor Class
Pharmaceutical industry-Indian
Responsible Party
Principal Investigator
Principal Investigator

Dr Robin Chugh

CCFT Laboratories

Study Sites (1)

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