| CTRI Number |
CTRI/2024/12/078461 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study to evaluate the moisturekinetic of the test product in healthy adult human subjects |
|
Scientific Title of Study
|
An evaluator-blind controlled-arm site-randomized split face moisturekinetic study of the test product Saslic Hydra Foaming Face Wash in healthy adult subjects |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240051-CL, Version 1.0, 07 Dec 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
clinical trial department, NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT
382481
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Clinical Trial Departmnt, NovoBliss Research Pvt. Ltd. office# 313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT
382481
India |
| Phone |
9909013286 |
| 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. 313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India
Clinical trial Department NovoBliss Research Pvt Ltd 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Cipla Ltd, R and D Centre, East Block,
2nd floor, L.B.S. Road, Vikhroli (West),
Mumbai- 400083, India.
|
|
|
Primary Sponsor
|
| Name |
Cipla Limited |
| Address |
Cipla Ltd, R and D Centre, East Block,
2nd floor, L.B.S. Road, Vikhroli (West),
Mumbai- 400083, India. |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Pvt. Limited |
Clinical Trial Department,
NovoBliss Research Pvt. Ltd.
Office# 313, Silver Radiance-4, Gota,
Ahmedabad- 382481, Gujarat, India
Ahmadabad
GUJARAT |
9909013286
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 |
normal, dry and sensitive skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not applicable |
| Intervention |
Saslic Hydra Foaming Face Wash |
Marketed by: Cipla Limited
Test Product: Saslic Hydra Foaming Face Wash
Mode of usage: Wet skin with lukewarm water, massage cleanser into skin in a gentle, circular motion, and rinse with water.
frequency: once a day
Duration: 02 Days
Dosage Form: Face Wash
Dose: required amount |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: 18 to 55 years (both inclusive) at the time of consent.
2.Sex: Healthy male and non-pregnant/non-lactating females.
3.Subject having normal, dry and sensitive skin.
4.Females of childbearing potential must have a self-reported negative pregnancy test.
5.Subject are generally in good health.
6.Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
7.If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
8.Subjects are willing to give written informed consent and are willing to come for regular follow up.
9.Subjects who commit not to use any other skincare products for the entire duration of the study.
10.Subject who have not participated in a similar investigation in the past three months.
11.Willing to use test product throughout the study period.
|
|
| ExclusionCriteria |
| Details |
1.History of any dermatological condition of the skin diseases.
2.Subject with present condition of allergic response to any cosmetic product.
3.Subject having allergic response to the ink.
4.Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy etc.) that might influence the outcome of the study.
5.Subjects who have applied topical treatment for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
6.History of alcohol or drug addiction.
7.Subjects using other marketed products during the study period.
8.Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
9.Pregnant or breastfeeding or planning to become pregnant during the study period.
10.History of chronic illness which may influence the cutaneous state.
11.Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare products within the last four weeks.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the effectiveness of test product in moisturizing the skin by measuring the skin hydration using Corneometer CM 825. |
from baseline before usage of the test product on Day 02 and after a single application of the test product 10 mins on Day 02, 2 hours, 4 hours, 8 hours, 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the effectiveness of the test product in terms of change in visual assessment of skin dryness, smoothness, roughness, redness, itchiness, and scaliness dermatologist or dermatologist trained evaluators.
2. To assess the effect of the test product in terms of subjective product perception
|
before test product usage will be done on Day 02, and after test product usage will be done at 10 min post usage, T1 2 hours, 4 hours, 8 hours, and 12 hours post application of the test product. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/12/2024 |
| Date of Study Completion (India) |
24/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="2" |
|
Recruitment Status of Trial (Global)
|
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
|
An evaluator-blind, controlled-arm, site-randomized, split face moisturekinetic study of the test product “Saslic Hydra Foaming Face Wash†in healthy adult subjects. Total 32 healthy adult males and non-pregnant/non-lactating females with an age of 18 – 55 years old. · Visit 01 (Day 01): Screening · Visit 02 (Day 02): Enrolment, Baseline evaluation, On site Product Usage, Post Usage Evaluation, End of the study. |