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.
Investigators
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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