An Exploratory, Evaluator-Blinded, Randomized, Interventional, Prospective Proof-of-Concept Study to Assess the Safety and Efficacy of Two Test Products in Female Subjects having Dark Spots, Acne Spots, Sunspots, Age Spots on their face.
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- S H Kelkar and Company Limited
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- 1.To evaluate the effectiveness of the test products in terms of change in skin color (L, a, b and ITA) using skin colorimeter flex CL 400 from baseline before usage of the test products and after usage of the test products and between the test product
Overview
Brief Summary
This is an exploratory, evaluator-blinded, randomized, interventional, prospective proof-of-concept study to assess the safety and efficacy of two test products in female subjects having dark spots, acne spots, sunspots, age spots on their face.
A total of 34 non-pregnant, non-lactating females (17 females/product) aged 18 to 55 years (inclusive), will be enrolled to ensure that 30 subjects (15 females/product) complete the study.
Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation.
Visit 02 (Day 30 +2 Days): Test Products Usage, Evaluations.
Visit 03 (Day 60 +2 Days): Final Evaluation, End of Study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 55.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Age: 18 to 55 years (both inclusive) at the time of consent.
- •Sex: Adults female subjects having dark spots/pigmentation caused by acne spots, sunspots age spots.
- •Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
- •Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin pigmentation in last 6 months.
- •Subjects must be willing to stop using any cosmetics or any medical products for skin pigmentation for the duration of the study.
- •Subjects are not allowed to participate in any other study until this study is complete.
- •Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
- •Subjects must agree to record each use of the test products in the subject’s diary card on daily basis.
- •Subjects must agree to record medication use during the study.
Exclusion Criteria
- •Subjects who are on steroids for last six months.
- •Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last six months.
- •Subjects with other dermatologic diseases whose presence or treatments could interfere with the assessment of study.
- •Subjects that are pregnant and/or breastfeeding.
- •The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances.
- •Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.
- •The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc.
- •which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
- •The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results.
- •The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.
Outcomes
Primary Outcomes
1.To evaluate the effectiveness of the test products in terms of change in skin color (L, a, b and ITA) using skin colorimeter flex CL 400 from baseline before usage of the test products and after usage of the test products and between the test product
Time Frame: On day 1, day 30 and day 60.
2.To evaluate the effectiveness of the test products in terms of change in skin erythema and melanin using Mexameter MX 18 from baseline before usage of the test products and after usage of the test products and between the test product.
Time Frame: On day 1, day 30 and day 60.
3.To evaluate the effectiveness of the test products in terms of change in skin texture i.e. skin roughness, smoothness, scaliness, wrinkles and finelines using VISIOSCAN VC 20 Plus from baseline before usage of the test products and after usage of the test products and between the test product.
Time Frame: On day 1, day 30 and day 60.
Secondary Outcomes
- 1. To evaluate the effectiveness of the test products in terms of changes in skin hyperpigmentation from baseline before usage and after usage of the test products, and between test products by using scoring scale.
- 2. evaluate the effectiveness of the test products in terms of changes in Glogau skin age classification from baseline before usage and after usage of the test products, and between test products by using scoring scale.(On day 1, day 30 and day 60.)
- 3. evaluate the effectiveness of the test products in terms of subjective product perception and non-comedogenic questionnaire assessment by using scoring scale(On day 1, day 30 and day 60.)
Investigators
Dr Nayan Patel
NovoBliss Research Private Limited