| CTRI Number |
CTRI/2024/10/074781 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Fabfil Efficacy check in Reducing Wrinkles depth |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Anti-Ageing Activity of Fabfil Efficacy in Reducing Depth of Wrinkles on Topical Application |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT 283 Version 1.0 dated 08 Aug 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
UTTAR PRADESH
250002
India |
| Phone |
7078103723 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Ramanathan |
| Designation |
Consultant |
| Affiliation |
MOHB GROWELL PRIVATE LIMITED |
| Address |
NEW NO.19 OLD NO.9, Dermat Dept, Ground Floor, VELAYUDAM STREET, NUNGAMBAKKAM, Chennai, Tamil Nadu, 600034
Chennai
TAMIL NADU
600034
India |
| Phone |
9444403001 |
| Fax |
|
| Email |
mohbgrowellchennai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Ramanathan |
| Designation |
Consultant |
| Affiliation |
MOHB GROWELL PRIVATE LIMITED |
| Address |
NEW NO.19 OLD NO.9, Dermat Dept, Ground Floor, VELAYUDAM STREET, NUNGAMBAKKAM, Chennai, Tamil Nadu, 600034
Aligarh
TAMIL NADU
600034
India |
| Phone |
9444403001 |
| Fax |
|
| Email |
mohbgrowellchennai@gmail.com |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, First floor, 135, Delhi Rd, besides Ramleela ground, New Punjabi Pura, Meerut, Uttar Pradesh 250002 |
| Mohb Growell Pvt Ltd, New no19, Velayudam St.Nungam Bakkam Chennai, 600034 |
|
|
Primary Sponsor
|
| Name |
Mohb Growell Pvt Ltd |
| Address |
New no19, Velayudam St.Nungam Bakkam Chennai, 600034 |
| 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
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 |
| Intervention |
Fabfil cream |
Approx 0.25gm Fabfil
Route of administration: Topical
Frequency: Once
Duration: 6 hours |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject with mentolabial fold or crow feet
2. Having apparently healthy skin on test area, For whom the investigator considers that the compliance will be correct.
3. Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
4. Having signed a Consent Form.
5. Should be able to read and write (in English, Hindi or local language).
6. Having valid proof of identity and age. |
|
| ExclusionCriteria |
| Details |
1. Pregnant or nursing mothers
2.Scars, excessive terminal hair or tattoo on the studied area
3.Henna tattoo anywhere on the body (in case of studies involving hair dyes)
4.Dermatological infection or pathology on the level of studied area
5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye)
6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures
7.Chronic illness which may influence the outcome of the study
8.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month)
9.Subject in an exclusion period or participating in another food, cosmetic or therapeutic trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in wrinkle depth |
0min, 30min, 2hour, 4hour, 6hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in skin Smoothness |
0min, 30min, 2hour, 4hour, 6hour |
| Change in Firmness |
0min, 30min, 2hour, 4hour, 6hour |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/10/2024 |
| 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="2"
Days="0" |
|
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
|
The clinical study would be done to Evaluate the Anti-Ageing Activity of Fabfil Efficacy in Reducing Depth of Wrinkles on Topical Application.
The Below assessments would be done. 1. wrinkle Depth 2. skin Firmness 3. Skin Smoothness 4. Dermascope Imaging
Study timepoints: 0min, 30min, 2hr, 4hr, and 6 hr.
|