Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: Niacinamide skin serum: Apply formulation once or twice daily
Sponsors
D9 Healthcare LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults with minor skin issues (25-75 years). 2.Fitzpatrick Skin Type 4 or 5 (Score 21-34). 3.No medication usage during the study. 4.Willing to prepare for Facial Skin Assessment. 5.Written informed consent to follow protocol. 6.Good general and mental health. 7.Willing to provide written informed consent. 8.Consistent dietary and skin product usage. 9.Willing to provide written informed consent. 10.Agree to take investigational product until Day 45 4.
Exclusion criteria
Exclusion criteria: 1.Participants having any clinically significant medical history, which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol. 2.Participants received any crosslinked HA filler in any anatomic area within the last 12 months. 3.Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to usual doses). 4.Participants who have participated in a clinical study during the preceding 180 days. 5. Participants with a medical history of using a medicated acne treatment within the last 6 months. 6. Participants with active skin disease in the test area. 7. Participants on systemic therapy with immuno-suppressive drugs (e.g., corticosteroids) and/or antihistamines within 7 days prior to the start of the study and/or throughout the entire course of the study. 8.Participants who are medically diagnosed with acne vulgaris, acne conglobate, fulminans, secondary acne (drug induced acne) or any acne requiring systemic or topical treatment. 9.Participants who had an aesthetic, cosmetic or dermatological treatment in the treatment area (face) within the last month. 10.Participants with a known or suspected intolerance, allergy, or hypersensitivity to study materials (or closely related compounds) or any of their stated ingredients. 11.Participants with a history of allergies to cosmetic products or medicated acne treatments. 12.Participants having eating disorders (i.e., bulimia, psychogenic eating disorders, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Dermatology Life Quality Index (DLQI)Timepoint: Baseline, Day 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in erythema scores assessed by Canfield VISIA -CR digital imagingTimepoint: Baseline, Day 45;Mean change in Physician Global Assessment scorTimepoint: Baseline, Day 45;Mean change in the Clinician s Erythema Assessment score (CEA)Timepoint: Baseline, Day 45;Local skin reactions after application by International Contact Dermatitis Research Group (ICDRG)Timepoint: Day 45;Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) over 45 days treatment periodTimepoint: Baseline, Day 15, Day 45 | — |
Countries
India
Contacts
Public ContactDr Manjyot Gautam
D. Y. Patil Deemed to be University, School of Medicine, Navi Mumbai
Outcome results
None listed