| CTRI Number |
CTRI/2022/07/043752 [Registered on: 06/07/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
efficacy and safety of
SilverNovaTM Skin Cream in Post aesthetic skin procedures subjects.
|
|
Scientific Title of Study
|
A Prospective, Interventional, open label, Multicentric study to evaluate the efficacy and safety of
SilverNovaTM Skin Cream in Post aesthetic skin procedures subjects.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avinash Bajirao Jadhav |
| Designation |
MD - Dermatologist |
| Affiliation |
Jyoti Multispecialty Clinic |
| Address |
B-Wing, Shop No. 03, Sai Pritam Nagari Apartment,
Kalewadi, Pune-17
Pune
MAHARASHTRA
413801
India |
| Phone |
7741970087 |
| Fax |
7276074767 |
| Email |
dravinashjadhav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harish S |
| Designation |
Director operation |
| Affiliation |
ICBio clinical research Pvt Ltd |
| Address |
#16 & 18 ICBio Tower, Yelahanka Main Road, Chikkabettahalli, Vidyaranyapura, Bangalore - 560 097, India
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harish S |
| Designation |
Director operation |
| Affiliation |
ICBio clinical research Pvt Ltd |
| Address |
#16 & 18 ICBio Tower, Yelahanka Main Road, Chikkabettahalli, Vidyaranyapura, Bangalore - 560 097, India
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Viridis BioPharma Pvt. Ltd
6/10, Jogani Industrial Complex, V N Purav Marg, Chunabhatti, Mumbai 400 022 |
|
|
Primary Sponsor
|
| Name |
Viridis BioPharma Pvt Ltd |
| Address |
6/10, Jogani Industrial Complex, V N Purav Marg,
Chunabhatti, Mumbai - 400 022
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja Kondadi |
Excel Hospital, |
1-5-56/29, Old Alwal Rd, beside Bharat Petroleum,
Near IG Statue, Banda Basti, Secunderabad, Telangana 500010
Hyderabad
TELANGANA |
9440664042
raviresearch5656@gmail.com |
| Dr Avinash Bajirao Jadhav |
Jyoti Multispecialty Clinic |
B-Wing, Shop No. 03, Sai Pritam Nagari Apartment,
Kalewadi, Pune-17
Pune
MAHARASHTRA |
7741970087
7276074767
dravinashjadhav@gmail.com |
| Dr Sanjay Purohit |
Maven’s Hospital |
N37, Vaishali Nagar, Ajmer 305001
Ajmer
RAJASTHAN |
9829279052
0145-2642799
dr.sanjay.ajmer@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Excel Hospital Institutional Ethics Committee |
Approved |
| Mavens Institutional Ethics Committee |
Submittted/Under Review |
| Royal pune independent ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L989||Disorder of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
SilverNova Skin Cream |
Twice a day, Morning and evening for 7 days external application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
1. Any dermatological disorder that, in the investigator’s opinion, may interfere with the accurate evaluation of the subject’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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
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
|
7 days treatment, followup on 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 subject’s face (right, left, and center full face) at Baseline and EOT to document visible changes in the skin.
|
7 days treatment, followup on 14th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/07/2022 |
| Date of Study Completion (India) |
21/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title of the study: “A Prospective, Interventional, open label,
Multicentric study to evaluate the efficacy and safety of SilverNovaTM Skin Cream in
Post 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 evaluate
the efficacy of SilverNovaTM Skin Cream in Post aesthetic
skin procedures subjects.
Secondary Objective:
To evaluate the safety and tolerability of SilverNovaTM Skin Cream in Post aesthetic skin procedures subjects. |