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Clinical Trials/CTRI/2013/05/003639
CTRI/2013/05/003639
Completed
未知

Evaluation of dermatological safety of investigational products by primary irritation patch test on healthy human volunteers of varied skin types. - NI

ITC R D Centre0 sites24 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
ITC R D Centre
Enrollment
24
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

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

Investigators

Eligibility Criteria

Inclusion Criteria

  • Subjects age group 18 \- 55 years
  • Healthy male \& female volunteers
  • Subjects with skin type III to V.
  • Subjects willing to give a written informed consent.
  • Subjects willing to maintain the patch test in position for 24 hours
  • Subject has not participated in a similar investigation in the past two weeks.
  • Subjects willing to come for regular follow up.
  • Subjects ready to follow instructions during the study period.

Exclusion Criteria

  • Infection, allergy on the tested area
  • Skin allergy antecedents or atopic subjects
  • Hyper sensitivity to any component of the tested products
  • Athletes and subjects with history of excessive sweating
  • Cutaneous disease which may influence the study result
  • Chronic illness which may influence the cutaneous state.
  • Subjects on oral corticosteroid with dose \>10mg/day
  • Subjects participating in any other cosmetic or therapeutic trial.
  • Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

Outcomes

Primary Outcomes

Not specified

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