Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified
Conditions
Interventions
Intervention1: SilverNova Skin Cream: Twice a day, Morning and evening for 7 days external application
Control Intervention1: NA: NA
Sponsors
Viridis BioPharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female subject between the age of 18 to 45 years. 2. Patients must have undergone Post aesthetic skin procedures which include: Chemical peeling (Tri Chloroacetic acid (TCA) cross peel, Yellow peel, Black peel, Glycolic peel etc.), Laser hair removal and Microneedling radiofrequency for atrophic acne scars. 3. The subjects were of general good health, had no obvious skin disease, known history of atopic dermatitis and/or skin elastosis on the face. 4. Subjects must be able to read, understand and provide written informed consent. 5. Individuals must agree to refrain from using any new products other than the assigned test materials. 6. Willingness not to use any moisturizer, cleanser, and/or sunscreen on the face other than the provided study product. 7. Subjects must agree to avoid excessive sun exposure and the use of artificial tanning methods. 8. Subjects must agree to arrive at their study visits with a clean face and without any products (lotions, creams, makeup, etc.) applied to their face. 9. Sexually active females of childbearing potential participating in the study must agree to use a medically-acceptable method of contraception while receiving study product. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. 10. Subjects free of any acute or chronic illness/disease that might interfere with or increase risk of study participation. 11. Subjects with no known allergy to any of the external applications
Exclusion criteria
Exclusion criteria: 1. Any dermatological disorder that, in the investigatorâ??s opinion, may interfere with the accurate evaluation of the subjectâ??s face. 2. Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products. 3. Concurrent therapy with any medication, either topical or oral, that might interfere with the study. 4. Subjects who have used a topical retinoid or other cosmeceutical preparation within 2 weeks of study enrollment, to include kojic acid, vitamin C, licorice extracts, alpha hydroxy acids etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The investigator evaluates, erythema, edema, dryness/scaling and global appearance issues 2. Subjects assessed product tolerability in terms of burning, stinging, itching, dryness/tightness Timepoint: 7 days treatment, followup on 14th day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percent reduction in dark scar by physician global improvement assessment scale from Baseline to EOT. 2. Lightening of the skin assessment using a Chromameter. 3. Assessment of safety of the Investigational products I. Adverse event II. Physical examination 4. Digital photography. Three images were taken of each subjectâ??s face (right, left, and center full face) at Baseline and EOT to document visible changes in the skin. Timepoint: 7 days treatment, followup on 14th day | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio clinical research Pvt Ltd
Outcome results
None listed