| CTRI Number |
CTRI/2024/01/061162 [Registered on: 05/01/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the 8hr moisturiziation potenial of samples |
|
Scientific Title of Study
|
A Clinical Study to evaluate the 8-hour moisturization potential of Multiple Saliguard
Samples at concentration 1.5% |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT148 Version 1.0 dated 11 Dec 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road Meerut Meerut UTTAR PRADESH 250002 India Meerut UTTAR PRADESH 250002 India
Meerut
UTTAR PRADESH
250002
India |
| Phone |
7078103723 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road Meerut Meerut UTTAR PRADESH 250002 India Meerut UTTAR PRADESH 250002 India
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
1st Floor room 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road Meerut Meerut UTTAR PRADESH 250002 India Meerut UTTAR PRADESH 250002 India
Meerut
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India |
| Salicylates & Chemicals Pvt. Ltd.
5 by 44, Tardeo Air-Conditioned Market,Tardeo Main Road, Tardeo, Mumbai central, Mumbai - 400 034, India |
|
|
Primary Sponsor
|
| Name |
Salicylates & Chemicals Pvt. Ltd. |
| Address |
5 by 44, Tardeo Air-Conditioned Market,Tardeo Main Road, Tardeo, Mumbai central, Mumbai - 400 034, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
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 Robin Chugh |
CCFT laboratories |
1st Floor room 3, Skin testing lab ,CCFT laboratories, AR multispecialty hospital and research center, Delhi Road Meerut Meerut Uttar Pradesh 250002 India Meerut UTTAR PRADESH 250002
Meerut
UTTAR PRADESH |
7078103723
robinderm25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ARMHRC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not Applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product: Multiple Serums-
Moisturizing Serum Blank, Moisturizing Serum with Saliguard LAU 1.5%, Moisturizing Serum with Saliguard LAS 1.5%, Moisturizing Serum with Saliguard LAG 1.5% |
Dose: Gently massage approx. 1 drop of serum over one block as
assigned (forearm)
Route of Administration: Topical
Duration: 8 Hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Gender: Male or Female with age 18-40
2) Subjects willing to give written informed consent
3) Women of child bearing potential must have a negative urine
pregnancy test prior to study entry.
4) Are free of any systemic or dermatologic disorder, which, in
the opinion of the investigator, will interfere with the study
results or increase the risk of adverse events.
5) Are willing to avoid prolonged exposure of the treatment area
to ultraviolet radiation (natural or artificial) for the duration of
the study.
|
|
| ExclusionCriteria |
| Details |
1. Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
2. Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
3. Have open sores or open lesions in the treatment area(s).
4. Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the
product.
5. Have participated in any interventional clinical trial in the previous 90 days.
6. Have a known sensitivity to any of the constituents of the test product.
7. Have used, are using, or are planning to use
immunosuppressive or immunomodulatory medication (i.e.,biologics), including corticosteroids.
8. Have not skin related issues |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Moisture |
T0min, T+30 mins, T+ 2 hours, T+4 hours, T+ 6 hours, T+8 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/01/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
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 open-label single-arm clinical study to evaluate moisturization. Test Product: Multiple Serums-
· Moisturizing Serum
Blank
· Moisturizing Serum with Saliguard LAU 1.5%
· Moisturizing Serum with Saliguard LAS 1.5% · Moisturizing Serum with Saliguard LAG 1.5% Dose: Gently
massage approx. 1 drop of serum over one block as assigned (forearm)
Route of Administration: TopicalSubjects will be on study for 1 day Screening & Assigning: Day 1 Follow-ups: on Day 1 |