| CTRI Number |
CTRI/2023/08/056537 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
17/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the effect of Plum Vitamin C serum for skin brightening. |
|
Scientific Title of Study
|
A single blind clinical study to evaluate the effectiveness and Safety of Plum Vitamin C serum for skin brightening. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT115/Plum1, Version 1.0 Dated 26 May 2023 |
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
First Floor, Room 4, Clinical Research Dept, Mittal Building, Mansarovar Ind Estate, Panchli Khurd, Baghpat 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 |
First Floor, Room 4, Clinical Research Dept, Mittal Building, Mansarovar Ind Estate, Panchli Khurd, Baghpat 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 |
First Floor, Room 4, Clinical Research Dept, Mittal Building, Mansarovar Ind Estate, Panchli Khurd, Baghpat 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
|
| Pureplay skin sciences Think Techno Campus, 1st Floor, Lodha, A Wing, Chirak Nagar, Thane, Maharashtra 400607 |
|
|
Primary Sponsor
|
| Name |
Pureplay skin sciences |
| Address |
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 multisepciality 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 |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Plum vitamin C serum |
Route of administration: Topical,
Frequency :1 gm twice in a day,
Duration: 28 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Female |
| Details |
1. Gender: Non-pregnant, non-lactating female aged between 18 to 34
2. Subject willing to give written informed consent
3. Women of child bearing potential must have a negative urine pregnancy test
4. Free of any systemic and dermatologic disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.
5. Are willing to avoid prolonged exposure of the treatment area 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 systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
3. Have open sore or open lesions in the treatment area
4. Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
5. Have participated in any interventional clinical trial in the previous 30 days.
6.Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.
7. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), including corticosteroids.
8. Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in percentage of consumers achieved a visible even tone skin/texture in 30 days.
2. Change in percentage of volunteers achieved a visibly brighter skin in 30 days.
3. Change in percentage of volunteers achieved a glowing skin in 30 days.
4. Change in percentage of volunteers experienced visible reduction of dark spot/ hyperpigmentation in 30 days
5. Change in percentage of volunteers experienced how much percentage of improvement in skin tone/texture. |
Day14, Day 28 |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/08/2023 |
| 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="15" |
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
|
Each participant entering the trial will be assigned to a regimen of investigational product, and advised to take general precautions as needed.Patients will be assigned to this study for 28 days in which Day 0 (Visit 1/Screening) done for screening purpose and handover the IP to the Subjects, and measure Melanin content by Mexameter, skin analysis by Spectrophotometer, Imagination of Dermis/ Epidermis, take HD picture by DSLR and Visio face scan/DJM scan. Additional on Day 14 or Visit 2 is required for doing subject assessment in which determination of the brightening of skin, dark spot intensity, tanning of skin, skin tone/texture, moisturizing level of skin and glowing of skin.Also, on the Day 14/ Visit 2 measure the physical characteristics which include texture of the test product, Spread-ability of the IP on the face and check the quickly absorption on the skin.On the Day 28/Visit 3/ Follow up, check the effect of IP by subject assessments and also any AE (Itching, Irritation and Burning sensation of the affected skin)
|