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Clinical Trials/CTRI/2022/09/045732
CTRI/2022/09/045732
Completed
Phase 2

Clinical study to evaluate the efficacy and safety of Sandalwood Rose Age Defying Eye Butter in healthy human subjects

Transformative Learning Solutions Pvt Ltd0 sites32 target enrollmentTBD

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Transformative Learning Solutions Pvt Ltd
Enrollment
32
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
November 24, 2022
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Transformative Learning Solutions Pvt Ltd

Eligibility Criteria

Inclusion Criteria

  • 1\.Female adult subjects in general good health as determined from a recent medical history.
  • 2\.Subjects in the age group of 30\-55 years (both ages inclusive).
  • 3\.Subjects having periorbital Melanosis/ under eye dark\- circle on grade 2 or more as per MSCR photo numerical scale (Refer Appendix\-2\)
  • 4\.Subject having eye puffiness in under eye area on grade 2 or more as per MSCR photo numerical scale (Refer Appendix\-2\)
  • 5\.Subject should be willing to abstain from other under eye treatment during the study period.
  • 6\.Subjects willing to give a voluntary written informed consent and agree to come for regular follow up.
  • 7\.Subject agreeable for photography.
  • 8\.Subjects willing to abide by and comply with the study protocol.
  • 9\.Subjects who have not participated in a similar investigation in the past two weeks.
  • 10\.Subjects who are willing not to participate in any other clinical study during participation in the current study

Exclusion Criteria

  • 1\.A known history or present condition of allergic response to any cosmetic products.
  • 2\.Subjects on oral medications (e.g. steroids, anti\-oxidant) which will compromise the study.
  • 3\.Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy.
  • 4\.Subjects having eye infection or allergy as per medical history.
  • 5\.Subjects having extremely sensitive eye condition.
  • 6\.Subjects having eye disorders like cataract, conjunctivitis, etc. as per medical history
  • 7\.Subjects who are pregnant, lactating or nursing.
  • 8\.Intense sun exposure/ photo allergen city/toxicity.
  • 9\.Chronic illness which may influence the cutaneous state.
  • 10\.Subject participating in any other cosmetic or therapeutic trial.

Outcomes

Primary Outcomes

Not specified

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