| CTRI Number |
CTRI/2024/11/077282 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Anti-sebum activity of Plum Green Tea & Zinc Sunscreen SPF 50 |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Anti-sebum activity of Plum Green Tea and Zinc Sunscreen SPF 50 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT 396 Version 1.0 dated 30 Oct 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 no 3, Skin testing lab , CCFT laboratories, AR multispecialty hospital and research center, Delhi Road
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 no 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 no 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 |
| Pureplay Skin Sciences India Pvt Ltd, 1st Floor Lodha I think Thane West 400604
|
|
|
Primary Sponsor
|
| Name |
Pureplay Skin Sciences India Pvt Ltd |
| Address |
1st Floor Lodha I think Thane West 400604
|
| 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 |
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: Plum Green Tea and zinc Sunscreen SPF-50 |
Test Product: Green Tea & Zinc Sunscreen SPF 50, Dose: Gently use the Green Tea & Zinc Sunscreen SPF 50 twice a day. , Route of Administration: Topical Duration: 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Gender: Male or Female with age 18-45
2) Subjects with Oily skin
3) Subjects willing to give written informed consent
4) Women of child bearing potential must have a negative urine
pregnancy test prior to study entry.
5) 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.
6) Are willing to avoid prolonged exposure of the treatment area
to ultraviolet radiation (natural or artificial) for the duration of
the study.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in skin Sebum
2. Change in Skin Smoothness
3. Change in Skin Gloss
4. Change in Open Pores |
Day 1-30mins, 1hr, 2hr, 4hr, Day7 and Day 14
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/12/2024 |
| 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
|
Test Product: Green Tea & Zinc Sunscreen SPF 50 Dose: Gently use the Green Tea & Zinc Sunscreen SPF 50 twice a
day for a 2 week. Route of Administration: Topical
Each participant entering the trial will be assigned to a regimen of
investigational product with the below assessments. - Skin Gloss by Glossymeter (T0, T30min, T1hr, T2hr, T4hr) - Skin Sebum(Oil) by Sebumeter (T0, T30min) - Open Pores count with Visioface/DJM(T0, T7, T14) - Dermat evaluation on a 5 point ordinal scale would be used for the
Skin Smoothness and Texture (T0 and T7, T14) - HD Imaging with DSLR or Visioscan (T0 and T14) |