CTRI/2018/12/016533
Completed
Phase 2
Efficacy evaluation of cosmetic formulation in conferring anti-skin aging benefits in healthy human volunteers - None
ITC Life Sciences Technology Centre0 sites40 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ITC Life Sciences Technology Centre
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subject is willing to give a written informed consent
- •2\.Subject is a healthy adult male and female in the age range of 35\-60 years
- •3\.Subjects with mild to moderate wrinkle crowââ?¬•s feet on scale 3 and above, referring to the Modified Anti\-Ageing Atlas\- 6 point scale.
- •4\.Subject has at least 2 dark spots on face that are age spots/lentigines\-marks other than melasma/chloasma.
- •5\.In case of having used fairness products/skin anti\-aging products in the near past subject willing to undergo a wash out period of 1 week, wherein they would abstain from applying any product other than the provided cleanser on face.
- •6\.Subjects willing to abstain from using any cosmetic/ medicinal/ ayurvedic/ natural products other than the one provided for testing on face during the study course.
- •7\.Female subjects of reproductive age group willing to undergo UPT at time of screening visit.
- •8\.Subject who shows good tolerance (no sensitivity symptoms) to the investigational products during the skin sensitivity test
Exclusion Criteria
- •1\.Subjects who are pregnant or lactating or contemplating pregnancy during the study course
- •2\.Subjects with a known history or present condition of allergic response/ sensitivity to sun, sunscreens/ cosmetics/ fragrances
- •3\.Subject having skin condition like psoriasis, atopic dermatitis or other cutaneous manifestations which would interfere with the test readings
- •4\.Subjects on medications like retinoid, steroids, antihistamines, oral contraceptives, or those for hormonal balance which could compromise the study results
- •5\.Subjects with tattoos, dense hair, moles, warts on face at the site of evaluation
- •6\.Subjects having participated in a similar investigation in the past 2 month
Outcomes
Primary Outcomes
Not specified
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