efficacy and safety ofSilverNovaTM Skin Cream in Post aesthetic skin procedures subjects.
Completed
- Conditions
- Disorder of the skin and subcutaneous tissue, unspecified,
- Registration Number
- CTRI/2022/07/043752
- Lead Sponsor
- Viridis BioPharma Pvt Ltd
- Brief Summary
**Title of the study**: “A Prospective, Interventional, open label,Multicentric study to evaluate the efficacy and safety of **SilverNovaTM Skin Cream** inPost aesthetic skin
procedures subjects.â€
**Study** **Duration:** 14 days study, Treatment for 7 days and followup on the 14th day.
**Study population**: 60 subjects **Study Endpoints:**
**Primary Objective:**To evaluatethe efficacy of **SilverNovaTM Skin Cream** in Post aestheticskin procedures subjects.
**Secondary Objective:**
To evaluate the safety and tolerability of **SilverNovaTM Skin Cream** in Post aesthetic skin procedures subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Male and female subject between the age of 18 to 45 years.
- 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.
- The subjects were of general good health, had no obvious skin disease, known history of atopic dermatitis and/or skin elastosis on the face.
- Subjects must be able to read, understand and provide written informed consent.
- Individuals must agree to refrain from using any new products other than the assigned test materials.
- Willingness not to use any moisturizer, cleanser, and/or sunscreen on the face other than the provided study product.
- Subjects must agree to avoid excessive sun exposure and the use of artificial tanning methods.
- 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.
- 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.
- Subjects free of any acute or chronic illness/disease that might interfere with or increase risk of study participation.
- Subjects with no known allergy to any of the external applications.
Exclusion Criteria
- Any dermatological disorder that, in the investigator’s opinion, may interfere with the accurate evaluation of the subject’s face.
- Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
- Concurrent therapy with any medication, either topical or oral, that might interfere with the study.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The investigator evaluates, erythema, edema, dryness/scaling and global appearance issues 7 days treatment, followup on 14th day 2. Subjects assessed product tolerability in terms of burning, stinging, itching, dryness/tightness 7 days treatment, followup on 14th day
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (3)
Excel Hospital,
🇮🇳Hyderabad, TELANGANA, India
Jyoti Multispecialty Clinic
🇮🇳Pune, MAHARASHTRA, India
Maven’s Hospital
🇮🇳Ajmer, RAJASTHAN, India
Excel Hospital,🇮🇳Hyderabad, TELANGANA, IndiaDr Pooja KondadiPrincipal investigator9440664042raviresearch5656@gmail.com