None listed
Conditions
Interventions
Intervention1: Demelan Nexa Serum: The product will be applied daily once daily of face for 28 Days
Control Intervention1: NIL: NIL
Sponsors
ERIS LIFESCIENCES LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects must meet all of the following criteria to be eligible for participation 2. Male or female subjects aged 18 to 45 years at the time of screening 3. Subjects with normal to mild acne prone skin defined as i Presence of 10 non inflammatory lesions open or closed comedones 4. Subject with clear to mild skin condition according to GAGS score 0 to 18 5. Fitzpatrick skin phototypes III to V 6.Intact healthy skin at the designated test area with i No cuts abrasions infection dermatitis or scarring 7.Subjects must be willing and able to i Comply with all study procedures ii Attend all scheduled visits iii Follow product application instructions 8.Willingness to avoid use of i Other cosmetic products ii Topical medications iii Acne treatments on the test area during the study period 9.Ability and willingness to provide written informed consent prior to any study related procedures 10.Ability to understand study instructions and communicate effectively with study staff
Exclusion criteria
Exclusion criteria: 1.Subjects meeting any of the following criteria will be excluded from participation 2. Presence of moderate to severe acne including: Inflammatory papules or pustules Nodules or cysts 3.History or presence of severe or chronic dermatological conditions including acne conglobata acne fulminans rosacea seborrheic dermatitis psoriasis eczema or vitiligo at the test area 4.Active skin infection bacterial viral or fungal at or near the test site 5.Excessive facial hair interfering with assessment 6.Use of topical acne treatments retinoids antibiotics benzoyl peroxide salicylic acid within 14 days prior to baseline 7.Use of systemic acne therapy including a.Oral antibiotics within last 4 weeks b.Oral isotretinoin within last 6 months 8.Use of topical corticosteroids or immunosuppressants on the test area within 2 weeks 9. Known hypersensitivity or allergy to a.Cosmetic products b.Any component of the investigational product 10.Presence of any uncontrolled systemic disease that in the investigatorâ??s opinion may interfere with study participation 11. Immunocompromised individuals 12.Pregnant or lactating women 13. Women planning pregnancy during the study period 14.Participation in any other clinical or cosmetic study within 30 days prior to screening 15.History of poor compliance or inability to follow study instructions 16.Any condition which in the investigatorâ??s opinion makes the subject unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in comedones count from baseline to Day 28 at the test site compared with the control siteTimepoint: Day 0, Day 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of new acne lesions Skin irritation signs: Erythema Dryness Scaling Pruritus Subject-reported discomfortTimepoint: Day 0, Day 14 and Day 28 | — |
Countries
India
Contacts
Public ContactMr Bharat Sharma
ZYFIS LIFESCIENCES PVT. LTD.
Outcome results
None listed