CTRI/2021/07/034591CompletedNot Applicable
An efficacy test to evaluate the skin benefits with regular use of Ayurvedic product
Unilever Industries Pvt Ltd1 site in 1 country576 target enrollmentStarted: July 7, 2021Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 576
- Locations
- 1
- Primary Endpoint
- Significant improvement in skin conditions by Expert assessment
Study Overview
Brief Summary
Study will be conducted to assess the efficacy of test product in imparting skin benefits. After consenting and qualifying the inclusion and exclusion criteria subjects will be enrolled into the study. Test product will be dispensed to subjects as per randomization and post base line assessment.
Subjects will be instructed to use the product twice a day and evaluation assessments will be done on week 2,week 4 and week 6.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Male and female subjects between 18 to 45 years of age.
- •(both age inclusive).
- •2.Healthy male and female subjects as per their medical history and medical examination.
- •3.Subjects with normal, oily or combination in skin type.
- •4.Subjects with common skin ailments.
- •5.Subjects who have not used fairness products in past 1 month as on the screening day.
- •6.Subject who agree not to use of any other products on their face during the study period.
- •7.Subject to agree not to carry out bleaching or any other skin care procedures on face during the study period.
- •8.Subject to agree to remove all jewellery on/around face (e.g., necklace, earrings, if possible, nose ring) during imaging.
Exclusion Criteria
- •1.Subjects presenting any skin ailment that may require medical intervention as per the investigator’s discretion.
- •2.Subjects with known skin condition that may impact the assessment.
- •3.Subject with any other signs of significant local irritation or skin disease.
- •4.Subject currently taking any medication, which the Investigator believes may influence the interpretation of the data.
- •5.Subject having chronic illness or had major surgery in the last year.
- •6.Subjects with dry to very dry skin, which will interfere with the test assessments.
- •7.Subjects undergoing any treatment of any skin condition on their face/forearm/body.
- •8.Subject allergic or sensitive to bar cleansing products, creams/lotions, artificial jewellery or anything else.
- •9.Subject pregnant or nursing.
- •10.Subjects taking medication including food supplements.
Outcomes
Primary Outcomes
Significant improvement in skin conditions by Expert assessment
Time Frame: Baseline, 2 weeks, 4 weeks & 6 weeks
Secondary Outcomes
- Significant improvement in skin conditions by instrumental assessment(Baseline, 2 weeks, 4 weeks & 6 weeks)
Investigators
Study Sites (1)
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