| CTRI Number |
CTRI/2025/03/082343 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
72-hours Moisturization for Galaxy (SA-CS-GD-1 and SA-CS-B-1) |
|
Scientific Title of Study
|
A clinical study to evaluate the 72-hours Moisturization potential of Galaxy (SA-CS-GD-1 and SA-CS-B-1) on healthy human volunteers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT530 Version 1.0 dated 24 Feb 2025 |
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
UTTAR PRADESH
250002
India |
| Phone |
9027285265 |
| 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
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
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, 250002 |
| Galaxy Surfactants Limited, Galaxy Research Centre, C-49/2, Ttc Industrial Area, Pawne, Navi Mumbai, Maharashtra 400703 |
|
|
Primary Sponsor
|
| Name |
Galaxy Surfactants Limited |
| Address |
Galaxy Research Centre, C-49/2, Ttc Industrial Area, Pawne, Navi Mumbai, Maharashtra 400703 |
| 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 |
AR multispecialty hospital and research center, 1st Floor room 3, Skin testing lab , CCFT laboratories, Delhi Road
Meerut
UTTAR PRADESH |
9027285265
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:
1. SA-CS-GD-1 (Cream with
active)
2. SA-CS-B-1 (Base Cream) |
Dose: Gently massage approx. 1 drop of over one block as assigned (forearm) Route of Administration: Topical Duration: 72 hour |
|
|
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 to ultraviolet radiation (natural or artificial)
|
|
| 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 years, or any other confounding skin condition.
3. Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
4. Have participated in any interventional clinical trial in the previous 90 days.
5. Have a known sensitivity to any of the constituents of the test product
6. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in hydration |
T0min, T30min, T+2hrs, T+8hrs, T+24hrs, T+ 48hours, T+72hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in TEWL |
t0min, t30min, t24hrs, t48hrs, t72hrs |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
19/03/2025 |
| 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="4" |
|
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
|
Test Product: 1. SA-CS-GD-1 (Cream with
active) 2. SA-CS-B-1 (Base Cream)
Dose: Gently massage approx. 1 drop of over one block as assigned (forearm) Route of Administration: Topical Duration: 72 hours |