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Clinical Trials/CTRI/2021/07/034826
CTRI/2021/07/034826
Completed
未知

To assess the skin irritation and sensitization potential of the 3 Investigational products by repeated application of occlusive patches.

Mr Amol Khedkar0 sites0 target enrollmentTBD
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Mr Amol Khedkar
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
Observational

Investigators

Sponsor
Mr Amol Khedkar

Eligibility Criteria

Inclusion Criteria

  • •1\.Healthy male and female volunteers aged 18 to 65 with no active dermatological conditions
  • •2\.Good general and mental health with, in the opinion of the investigator or medically qualified designee with no clinically significant and relevant abnormalities in medical history or upon physical examination
  • •3\.Subjects who have intact skin on the proposed application site; dorsum (scapular region)
  • •4\.Fitzpatrick photo type I to IV skin type
  • •5\.Willingness to participate as evidenced by voluntary written informed consent

Exclusion Criteria

  • •Exclusion Criteria:
  • •1\.Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
  • •2\.Women who are breast\-feeding
  • •3\.Any history of significant dermatological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction.
  • •4\.Presence of open sores, pimples, or cysts at the application site.
  • •5\.Active dermatosis (local or disseminated) that might interfere with the results of the study.
  • •6\.Considered immune compromised.
  • •7\.History of diseases aggravated or triggered by ultraviolet radiation.
  • •8\.Participants with dermatographism.
  • •9\.Currently using any medication which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.

Outcomes

Primary Outcomes

Not specified

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