| CTRI Number |
CTRI/2024/02/062644 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to determine the safety and efficacy of the test products. |
|
Scientific Title of Study
|
Prospective, Interventional, Proof-of-Science, Randomised, Evaluator-Blinded, In-Use Safety and Efficacy Study of Two Moisturising Creams in Wound-Healing. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240002-SH_Version_Final (1.0)_01Feb24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT
382421
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT
382421
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT
382421
India |
| Phone |
09909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Keva – S H Kelkar and Company Limited
LBS Marg, Mulund (West),
Mumbai – 400 080, India |
|
|
Primary Sponsor
|
| Name |
S H Kelkar and Company Limited |
| Address |
LBS Marg, Mulund (West), Mumbai- 400080 Maharashtra - India |
| Type of Sponsor |
Other [Manufacturer - Cosmetics] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
NovoBliss Research Private Limited |
Clinical Trails Department,
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj
Gandhinagar
GUJARAT |
09909013286
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS – Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Adults with no history of significant skin diseases. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product A (moisturising cream) |
Dosage Form: Cream
Duration: 7 Days
Route of Administration: Topical
Frequency: Twice A Day
Dose: 0.2 ml/Site
Mode of Usage: Apply on the designated wound site till absorbed. |
| Intervention |
Test Product B (Moisturising cream) |
Dosage Form: Cream Duration: 7 Days Route of Administration: Topical Frequency: Twice A Day Dose: 0.2 ml/Site Mode of Usage: Apply on the designated wound site till absorbed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. The subject is aged between 18 and 55 years (both inclusive) at the time of informed consent.
2. The subject is a non-pregnant, non-lactating healthy adult female.
3. No previous history of adverse skin conditions, and not under any medication likely to interfere with the results.
4. The subject has a self-reported negative urine pregnancy test.
5. The subject is in a good general health as determined from recent medical history.
6. The subject has willingness and ability to adhere to study directions, and agrees not to use any other skin creams, lotions, serums, etc. at the application sites, except for the specified test products, and return for all specified visits.
7. The subject possesses the ability to comprehend and provide written informed consent for participation in the study.
|
|
| ExclusionCriteria |
| Details |
1. The subject is currently pregnant or lactating or is planning to become pregnant during the study period.
2. The subject has a history of allergies or specific allergic reactions upon using dermatological or cosmetic products.
3. The subject is currently enrolled in an active investigational study or has participated in an investigational study within 30 days prior to enrolment.
4. The subject suffers from any active clinically significant disease or any condition that according to the discretion of the investigator warrants exclusion from the study.
5. The subject is taking or has taken a medication which, in the judgement of the Investigator, makes the subject ineligible or places the subject at undue risk.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the efficacy of the test products in healing of the wounds on skin, in terms of change in skin barrier function.
2. To assess the efficacy of the test products in healing of the wounds on skin, in terms of change in skin hydration.
3. To assess the efficacy of the test products in healing of the wounds on skin, by evaluating the skin surface topography in terms of skin roughness, wrinkles, scaliness, smoothness, and a 3D skin ultrasound.
|
On Day -01, at two time-points on Day 01 (pre-dose and post dose at T12 hours), and subsequently on Days 02, 03, and 07. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the efficacy of the test products in healing of the wounds on skin, in terms of change in skin irritation, dryness, scaling, peeling, itching, swelling, and smoothness. |
On Day -01, at two time-points on Day 01 (pre-dose and post dose at T12 hours), and subsequently on Days 02, 03, and 07. |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/02/2024 |
| Date of Study Completion (India) |
28/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="7" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an evaluator-blinded, in-use safety and efficacy study of wound-healing properties of two test products. A maximum of 17 subjects will be recruited to ensure the completion of the study with a total of 15 subjects. Subjects will be instructed to visit the facility for the following scheduled visits:
- Visit 1: Day (-01): Screening, Enrolment, Site cleaning, Site demarcation, Baseline Scoring, Instrument Evaluations, 24 hours patch Application
- Visit 2: (Day 01 (24 hours post patch application): Patch removal, irritation scoring, instrumental evaluations, 24 times tape stripping on designated sites, application sites photographs, product Application to the sites, instrumental evaluation post-dose
- Visit 03 [Day 02 (24 hours post dose) + 1 day]: Irritation Scoring, Instrument Evaluation
- Visit 04 [Day 03, (48 hours post dose) + 1 day]: Irritation Scoring, Instrument Evaluations
- Visit 05 [Day 07 + 1 day]: Irritation Scoring, Instrument Evaluations, Application Sites Photograph
|