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Clinical Trials/CTRI/2023/12/060705
CTRI/2023/12/060705
Completed
未知

A Clinical Study to evaluate the skin irritation potential of Help Us Green Multiple Gulal colors on healthy human subjects. - NI

Help Us Green LLP0 sites0 target enrollmentTBD
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Help Us Green LLP
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Help Us Green LLP

Eligibility Criteria

Inclusion Criteria

  • •1\. Voluntary man/women between 18 and 65 years.
  • •2\. Photo type III to V.
  • •3\. Having apparently healthy skin on test area
  • •4\. For whom the investigator considers that the compliance will be correct.
  • •5\. Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
  • •6\. Having signed a Consent Form.
  • •7\. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study.
  • •8\. 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.
  • •9\. Should be able to read and write (in English, Hindi or local language).
  • •10\. Having valid proof of identity and age.

Exclusion Criteria

  • •1\. Pregnant/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/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

Not specified

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