| CTRI Number |
CTRI/2024/02/062978 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| 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 safety and efficacy of Plum serum in Hair Growth |
|
Scientific Title of Study
|
A clinical study to evaluate the safety and efficacy of Plum serum in Hair Growth and hairfall with Phototrichogram. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT162 Version 1.0 dated 19 Jan 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 |
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
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 |
| Pureplay Skin Sciences India Pvt Ltd
I Think Techno Campus, 1st Floor, Lodha, A Wing, Chirak Nagar, Thane, Maharashtra 400607 |
|
|
Primary Sponsor
|
| Name |
Pureplay Skin Sciences India Pvt Ltd |
| Address |
I Think Techno Campus, 1st Floor, Lodha, A Wing, Chirak Nagar, Thane, Maharashtra 400607 |
| 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 |
Hair fall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product- Hair Growth Serum
|
Dose: approx. 0.5 to 1 ml with help of dropper on bald area with gentle massage. Twice a day Route of Administration: Topical Duration: 86 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Indian or Asian female and male subjects with max Female : Male Ratio – 80:20 with Stage 2 and 3
2. Healthy subjects (no infectious and evolutive
pathology which could make the subject
vulnerable and stop the study, no pathology
which could interfere with the study, no
symptomin the process of an exploratory
checkup)
3. Between 25 and 40 years of age.
4. Skin is healthy on the studied anatomic unit (free of eczema, wounds, inflammatory scar….)
|
|
| ExclusionCriteria |
| Details |
• Being pregnant or breastfeeding or having stopped to breastfeed in the past three months
• Having refused to give her assent by not signing the consent form
• Taking part in another study liable to interfere with this study
• Having a chronic dermatosis liable to modify the
cutaneous reactivity on the tested area
• Being insulin-dependent diabetic or non insulindependent diabetic with a recent therapy (less
than 6 months)
• Having a progressive asthma (either under
treatment or last fit in the last 2 years)
• Being epileptic
• Having non stabilized thyroid problems
(requirement of a stabilized treatment for at
least 6months)
• Having cutaneous hypersensitivity
• Having a diagnosed or highly probable allergy
to one or several compounds of the cosmetic
products
• Following a chronic or intermittent medicinal
treatment comprising any of the following
products : aspirin-based products, antiinflammatories, anti-histamines, anti-coagulants, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol)
• Having undergone a surgery requiring a general
anaesthetic of more than one hour in the past6
months
• Having changed her cosmetic habits except
those required by the protocol in the 14
dayspreceding the start of the study on the
studied anatomic unit
• Having applied a cosmetic product on the
studied areas the first day of the study (except
theusual shampoo) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Hair growth |
T0min, T+2 days, T+28 days ,T+30 days, T+56 days T+58
days, T+84 days and T+86 days |
|
|
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)= "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)
|
26/02/2024 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Single arm clinical study to evaluate the safety and efficacy of plum serum in Hair Growth and hairfall.
1. Plum Hair Growth Serum
The products will be tested for skin irritation on 24 human volunteers. Assessment would Notice improvement in Hairline / Bald patches with followup visit on T0min, T+2 days, T+28 days ,T+30 days, T+56 days T+58 days, T+84 days and T+86 days
Study is done as per BIS standard 4011 |