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Clinical Trials/CTRI/2019/04/018444
CTRI/2019/04/018444
Completed
未知

To Evaluate Dermatological Safety of Investigational Products by 24 Hours Patch Test Under Complete Occlusion on Adult Healthy Human Subjects with Non-Sensitive and Sensitive Skin

Dabur India Limited0 sites24 target enrollmentTBD
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Dabur India Limited
Enrollment
24
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
April 23, 2019
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Healthy male and female subjects (1:1 ratio) in the age group of 18\-65 years (both age inclusive) with non\-sensitive skin
  • •2\. Subjects scoring more than 30 for Section 2\- Sensitive v/s Resistant skin in modified Dr. Baumannâ??s skin type questionnaire. Please see detail annexure II
  • •3\. Subjects representing with normal, oily, dry and combination skin type in equal ratio.
  • •4\. Subjects with normal Fitzpatrick skin type III to V.
  • •5\. Female subjects with child bearing potential willing to undergo Urine Pregnancy Test.
  • •5\. Subjects free from excessive hair, cuts, wounds, irritation symptoms, abrasion or any other skin condition which may interfere in the study results.
  • •6\. Subjects willing to give voluntary written informed consent.
  • •7\. Subjects willing to maintain the patch test in position for 24 hours.
  • •8\. Subject having not participated in a similar investigation in the past two weeks.
  • •9\. Subjects willing to come for regular follow up visits.

Exclusion Criteria

  • •1\. Infection, allergy on the tested area.
  • •2\. Skin allergy antecedents or atopic subjects.
  • •3\. Subjects with known hypersensitivity to any of the study products or constituents.
  • •4\. Subjects with any significant skin pathology in the investigational area
  • •5\. Athletes and subjects with history of excessive sweating.
  • •6\. Cutaneous disease which may influence the study result.
  • •7\. Subjects using any topical or systemic treatment that could interfere with the study treatments/assessments within the last 4 weeks prior to participation in the study and during the study.
  • •8\. Subjects on oral corticosteroid
  • •9\. Subjects participating in any other cosmetic or therapeutic study.
  • •10\. Female subjects who are pregnant or lactating.

Outcomes

Primary Outcomes

Not specified

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