| CTRI Number |
CTRI/2024/04/066437 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the 24 hours moisturization potential of Moisturizing cream. |
|
Scientific Title of Study
|
A Clinical Study to evaluate the 24 hours moisturization potential of Aqualogica Barrier Repair Moisturizer. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT169 Version 1.0 dated 10 Feb 2024 |
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 |
| 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 |
| 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 |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, 135, Punjabipura, Delhi Road, Meerut, India |
| Honasa Consumer Ltd. 10th &11th Floor, Capital Cyberscape Sector 59, Gurugram, Haryana, India -122101 |
|
|
Primary Sponsor
|
| Name |
Honasa Consumer Ltd. |
| Address |
10th &11th Floor, Capital Cyberscape Sector 59, Gurugram, Haryana, India -122101 |
| 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 |
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 |
Skin moisturizing |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aqualogica Barrier+ repair Moisturizer |
Dose: Gently massage approx. 2-3 drop of serum over one block, for 2-3 minutes.
Route of Administration: Topical |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Gender: Male or Female 18 to 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
5.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/or 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 |
| To study the skin hydration |
At T0, T+30Min, T+2hrs, T+4hrs, T+6hrs, T+8hrs, T+24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the safety and tolerability |
At T0 and 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
A single blind one arm study. Each participant entering the trial will be assigned to a regimen of investigational product, and advised to take general precautions as needed.
Subjects will be on study for 24hrs. Screening & Assigning: Day 0 Test Product: Aqualogica Barrier Repair Moisturizer Dose: Gently massage approx. 2-3 drop of serum over one block Route of Administration: Topical |