None listed
Conditions
Interventions
Intervention1: Kojic Acid Dipalmitate Serum: Manufactured by: Cerca Trova LLP
Marketed By: Amvigor Organics Pvt Ltd
Mode of Usage: Apply 3-5 drops to clean and dry skin of the entire face. Pat it in g
Sponsors
Cerca Trova LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: between 18 to 55 years at the time of consent. 2) Sex: Adult male and female having facial hyperpigmentation and dark spots such as tan, melasma , acne marks, sunspots, age spots, uneven skin tone on face. 3) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit. 4) Participants should not have used any cosmetic, nutraceutical or therapeutic products for dark spots in last 3 months. 5) Participants must be willing to stop using any cosmetics or any medical products for dark spots for the duration of the study. 6) Participants are not allowed to participate in any other study until this study is complete. 7) Participants must be willing and able to follow the study directions and to return for all specified visits with the product. 8) Participants must agree to record each use of the test products in the participant s diary card on daily basis.
Exclusion criteria
Exclusion criteria: 1) Participants who are on steroids for last six months. 2) Participants who have used any cosmetic, nutraceutical or therapeutic products for skin last three months. 3) Participants who are on product which contains kojic acid, glycolic acid, niacinamide, alpha arbutin, Vitamin C and other skin product. 4) Participants with other dermatologic diseases whose presence or products could interfere with the assessment of study. 5) History of hypersensitivity to any cosmetic products. 6) Use of depigmenting products (e.g., chemical peels, lasers, hydroquinone-based products) within 4 weeks prior to baseline. 7) Participants that are pregnant and/or breastfeeding. 8) The participant has a known allergy or sensitivity to product ingredients. 9) Participants if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure. 10) The participant is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.To evaluate the effectiveness of the test product in terms of change in skin colour parameters - L, a, b, and ITA from baseline before usage and after usage of the test product, within the product group and between product groups. 2.To evaluate the effectiveness of the test product in terms of change in skin melanin and erythema from baseline before usage and after usage of the test product, within the product group and between product groups. Timepoint: 1.To evaluate the effectiveness of the test product in terms of change in skin colour parameters - L, a, b, and ITA using Skin Colorimeter CL 400 from baseline before usage of the test product on Day 01 and after usage of test product at T20 mins on Day 01, Day 14, Day 30 and Day 60 within the product group and between product groups. 2.To evaluate the effectiveness of the test product in terms of change in skin melanin and erythema using Mexameter MX 18 from baseline before usage of the test product on Day 01 and after usage of test product at T20 mins on Day 01, Day 14, Day 30 and Day 60 within the product group and between product groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. To evaluate the effectiveness of the test product in terms of change in trans epidermal water loss of skin from baseline before usage and after usage of the test product, within the product group and between product groups.Timepoint: From baseline before usage of the test product on Day 01 and after usage of test product at T20 mins on Day 01, Day 14, Day 30 and Day 60;3. To evaluate the effectiveness of the test product in terms of change in skin melasma from baseline before usage and after usage of the test product, within the product group and between product groups.Timepoint: From baseline before usage of the test product on Day 01 and after usage of test product at T20 mins on Day 01, Day 14, Day 30 and Day 60;4. To evaluate the effectiveness of the test product in terms of change in spot colour intensity, average size and number, pigmentation intensity and contrasts from baseline before usage and after usage of the test product, within the product group and between product groups.Timepoint: From baseline before usage of the test product on Day 01 and after usage of test product at T20 mins on Day 01, Day 14, Day 30 and Day 60;5. To evaluate the effectiveness of the test product in terms of change in visual appearance from baseline before usage and after usage of the test product, within the product group and between product groups.Timepoint: From baseline before usage of the test product on Day 01 and after usage of test product at T20 mins on Day 01, Day 14, Day 30 and Day 60;6. To evaluate the effectiveness of the test product in terms of change in Product Perception Questionnaire from baseline before usage and after usage of the test product, within the product group and between product groups.Timepoint: From baseline before usage of the test product on Day 01 and after usage of test product at T20 mins on Day 01, Day 14, Day 30 and Day 60;Safety will be determined by product and control emergent adverse events such as erythema, stinging sensation, pruri | — |
Countries
India
Contacts
Public ContactDr Maheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed