MedPath

skin saftey test of Herbscrubb Perfume

Not yet recruiting
Conditions
Not Applicable
Registration Number
CTRI/2025/03/083460
Lead Sponsor
Herbscrubb
Brief Summary

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|The below products would be tested as per the guideline IS4011 for dermal safety assessment.  

1.Perfume



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

Assessment would be done on day 0, day 3, with followup visit on day 8 for erythema and Oedema scoring

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
24
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change in Skin Irritation Score-erythema & oedemaDay 0, Day 2 and Day 8
Secondary Outcome Measures
NameTimeMethod
Not ApplicableNot Applicable

Trial Locations

Locations (1)

CCFT laboratories

🇮🇳

Meerut, UTTAR PRADESH, India

CCFT laboratories
🇮🇳Meerut, UTTAR PRADESH, India
Dr Robin Chugh
Principal investigator
9027285265
robinderm25@gmail.com

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