| CTRI Number |
CTRI/2024/12/078638 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Anti-acne activity of Plum Salicylic Acid Face Wash |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Anti-acne activity of Plum Salicylic Acid Face Wash |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT429 Version 1.0 dated 12 Dec 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
UTTAR PRADESH
250002
India |
| Phone |
8937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| Pureplay Skin Sciences India Pvt Ltd, 403, Valentina, Hiranandani Estate Thane, West Thane, Maharashtra 400607 |
|
|
Primary Sponsor
|
| Name |
Pureplay Skin Sciences India Pvt Ltd |
| Address |
403, Valentina, Hiranandani Estate Thane, West 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 |
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 Salicylic Acid Face Wash |
Test Product: Plum Salicylic Acid Face Wash
Dose: Gently use approx. 1gm Plum Salicylic Acid Face Wash twice a day for a week. Rinse well. Route of Administration: Topical. Duration: 14 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Gender: Male or Female with age 18-40, and Female:Male ratio of 80:20 approximately
2)Subjects with visible acne
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 Acne
2.Change in Skin Cleaning
3.Change in TEWL
4. |
T0min, T+30 mins, T2hrs, T+3 days, T+7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
04/01/2025 |
| 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="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
|
A single blind one arm study Test Product: Plum Salicylic Acid Face Wash Dose: Gently use approx. 1gm Plum Salicylic Acid Face Wash twice a day for a week. Rinse well. Route of Administration: TopicalFollow-ups: on Day 0 Day7 and Day 14
Assessment points- 1.Acne Count 2. Skin pH 3. TEWL |