Topical niacinamide in graded concentrations on skin health metrics in Indian wome

Phase 2

• Registration Number: CTRI/2024/02/063151
• Lead Sponsor: asons India Pvt. Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified