None listed
Conditions
Interventions
Intervention1: Group A: Niacinamide USP (GLOShine B3™) (10%): application in the morning as well as before the bedtime.
Intervention2: Group B: Niacinamide USP (GLOShine B3™) (15%): application in the
Sponsors
Lasons India Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female of 18 to 40 years, willing to give a written informed consent and come for regular observations; 2.Subject with dull complexion, dry/oily skin with/ without uneven texture, and with at least 2 hyperpigmentary spots as a result of photodamage; 3.Subject has not participated in a similar clinical investigation in the past three months; 4.Subject who is willing to abstain from using any fairness product, natural/ Ayurvedic treatments or other home remedies and also willing to abstain from undergoing any facial treatments; 5.The subject should use a light moisturizer followed by broad-spectrum sunscreen for daily use along with an investigational product; 6.Willingness to complete questionnaires, records, and diaries associated with the study and to complete all visits.
Exclusion criteria
Exclusion criteria: 1.Participants with any chronic illness or any clinical condition; 2.Participants who have used a Niacinamide USP (GLOShine B3™) in the past 1 month and those who had taken high doses of vitamin C (Greater than or equal to 500 mg a day) or any other antioxidant product in the past 1 month; 3.Participants who have done any topical, systemic, laser, and surgical treatment on face during the previous year; 4.Participants with known allergies or sensitivities to niacinamide or associated substances; 5.Those having a history of skin cancers, especially melanoma; 6.People with specific preexisting skin disorders or diseases. This might include, aggressive acne, eczema, or disorders like psoriasis; 7. Participation in other clinical trials in last 90 days prior to screening; 8.Females who are pregnant and have a positive urine pregnancy test/planning to be pregnant/lactating or not using reliable methods of contraception; 9.Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes; 10.Participants who show hypersensitivity or allergic reactions after a patch test of the investigational product (observe for 24 hours).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in cutaneous pigmentation evaluated by a dermatologist based on Melasma Area and Severity Index (MASI) 2.Changes in under-eye dark circles for four zones 3.Changes in elasticity of the skinTimepoint: Niacinamide USP (GLOShine B3™)(10%) at screening, day 15 and day 30 Niacinamide USP (GLOShine B3™) (15%) at screening, day 7 and day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of the study include assessment of an Niacinamide USP (GLOShine B3™) (10%) and Niacinamide USP (GLOShine B3™) (15%) at baseline and end of the study by evaluating alterations in skin hydration, skin texture and roughness, skin tone, dullness of the skin, wrinkles, blemishes, average pore volume, gauging overall self-esteem, and measuring patient’s satisfaction along with investigational product safety via assessment of vital signs, compliance, tolerability and monitoring of adverse events.Timepoint: Niacinamide USP (GLOShine B3™)(10%) at screening, day 15 and day 30 Niacinamide USP (GLOShine B3™) (15%) at screening, day 7 and day 15 | — |
Countries
India
Contacts
Public ContactMr Jeetesh Gidwani
Mprex Healthcare Pvt. Ltd.
Outcome results
None listed