| CTRI Number |
CTRI/2026/01/100932 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Skin Dryness and Soothing Effects of Benzoyl Peroxide Versus Polymer-Based Benzoyl Peroxide Formulations in Acne Treatment |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the Skin Dryness and Soothing Effects of Benzoyl Peroxide Versus Polymer-Based Benzoyl Peroxide Formulations in Acne Treatment |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT1074 Version 1.0 dated 26 Dec 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Robin Chugh |
| Designation |
Principal Investigator |
| Affiliation |
CCFT Laboratories |
| Address |
Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
09027285265 |
| Fax |
|
| Email |
robinderm25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Mittal |
| Designation |
Clinical Research Consultant |
| Affiliation |
CCFT Laboratories |
| Address |
Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road, Meerut, UTTAR PRADESH-250005 |
| Wallace Pharmaceuticals Pvt. Ltd., R&D Centre Nirancal Road Ponda Goa- 403409 |
|
|
Primary Sponsor
|
| Name |
Wallace Pharmaceuticals Pvt. Ltd. |
| Address |
R&D Centre Nirancal Road Ponda Goa- 403409 |
| 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 |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
Meerut
UTTAR PRADESH |
09027285265
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 |
Polymer-Based Benzoyl Peroxide |
Test Product: Polymer-Based Benzoyl Peroxide Dose:Apply 5 % Benzoyl peroxide is 2-3 times a day. Route of Administration: Topical (Acne affected area) |
| Intervention |
Test product: Benzoyl Peroxide |
Test Product: Benzoyl Peroxide
Dose: Apply 5 % Benzoyl peroxide is 2-3 times a day. Route of Administration: Topical (Acne affected area)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Gender: Male and Female(50:50) aged Between 18-35.
2.Non-pregnant, non-lactating female
3.Subject with acne and normal to oily skin.
4.Subject willing to give written informed consent
5.Women of child bearing potential must have a negative urine pregnancy test.
6.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.
7.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.Subjects having Moderate to severe pigmentation, sunburn, scar or any type of skin concern.
3.Volunteers with skin conditions such as eczema, psoriasis, etc
4.Have any evidence of systematic cancer, squamous cell carcinoma, basal cell carcinoma in the last 5 years, or any other confounding skin condition.
5.Have open sore or open lesions in the treatment area
6. Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
7.Have participated in any interventional clinical trial in the previous 30 days.
8.Have a known sensitivity to any of the constituents of the test product including sensitivities to any of the constituents.
9.Have used, are using, or are planning to use immunosuppressive or immunomodulatory medications (i.e., biologics), including corticosteroids.
10.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 |
Change in Skin Hydration
Change in TEWL
Change in Sebum
Smoothness
Acne count |
T0, T30min, T4hr, T8hr, T24hrs, T14days |
|
|
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)
|
22/01/2026 |
| 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="14" |
|
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
|
This study will be conducted as a comparative, split-face clinical study. Each participant entering the trial will be assigned to a regimen of the investigational product in a split-face manner, wherein one side of the face (left or right) will receive the test product and the contralateral side will receive the comparator. Assessments All assessments listed in the study design will be performed separately on each side of the face at the defined time points. Instrumental Assessments: •Skin Hydration (Corneometer): (0, 30min, 4hr, 8hr, 24hr and 14 day) •TEWL (Tewameter): (0, 30min, 24hr, 14 day) •Skin Sebum (Sebumeter): (0, 14 day) •Acne Count by Visio scan: (0, 14 day) Dermatological Evaluations (5-Point Ordinal Scale): •Smooth Skin •Calm Skin •Skin Roughness Imaging Assessment: •High-Definition Facial Imaging using DSLR camera 30-Minute Post-Application Assessment- At 30 minutes post first application, immediate effects of the product will be assessed on each facial side for: •Skin Hydration (Corneometer) •TEWL (Tewameter) |