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Clinical Trials/CTRI/2017/02/007849
CTRI/2017/02/007849
Completed
Phase 2

Evaluation of dermatological safety of investigational products by 24hrs patch test under complete occlusion on healthy human subjects

Dabur India Limited0 sites0 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Dabur India Limited
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

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

  • •1\.Subjects in age group 18 \- 55 years (both the ages inclusive)
  • •2\.Healthy male \& female subjects.
  • •3\.Subjects with normal Fitzpatrick skin type III to V.
  • •4\.Subjects willing to give a voluntary written informed consent.
  • •5\.Subjects willing to maintain the patch test in position for 24 hours.
  • •6\.Subject having not participated in a similar investigation in the past two weeks.
  • •7\.Subjects willing to come for regular follow up visits.
  • •8\.Subjects ready to follow instructions during the study period.

Exclusion Criteria

  • •1\.Infection, allergy on the tested area.
  • •2\.Skin allergy antecedents or atopic subjects.
  • •3\.Athletes and subjects with history of excessive sweating.
  • •4\.Cutaneous disease which may influence the study result.
  • •5\.Subjects on oral corticosteroid.
  • •6\.Subjects participating in any other cosmetic or therapeutic study.
  • •7\.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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