| CTRI Number |
CTRI/2025/09/094362 [Registered on: 08/09/2025] 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
|
Reginald men Apollo Facewash for skin brightening and hydration |
|
Scientific Title of Study
|
A Clinical study to Evaluate the effectiveness of Reginald men Apollo Facewash for skin brightening and hydration |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT779 Version 1.0 dated 06 Aug 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 |
CCFT Laboratories, 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 |
CCFT Laboratories, 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 |
CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road
UTTAR PRADESH
250005
India |
| Phone |
08937015757 |
| Fax |
|
| Email |
puneetmittal@mgcts.org |
|
|
Source of Monetary or Material Support
|
| Btm Ventures Private Limited, Hd-062, Sy-11, Krishe Emerald Serlingampally Mandal, Kondapur, Rangareddi, Hyderabad- 500081 |
| CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road, Meerut, UTTAR PRADESH-250005 |
|
|
Primary Sponsor
|
| Name |
Btm Ventures Private Limited |
| Address |
Hd-062, Sy-11, Krishe Emerald Serlingampally Mandal, Kondapur, Rangareddi, Hyderabad- 500081 |
| 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 |
Not Applicable |
Not Applicable |
| Intervention |
Test Product: Reginald men Apollo Facewash |
Test Product: Reginald men Apollo Facewash
Dose: Gently use the Reginald men Apollo Facewash twice a day for 4 weeks . Rinse well.
Route of Administration: Topical
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Gender: Male and Female with age 18-45 (80:20)
2) Subjects with mild blemishes and dull skin.
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 |
| Details |
1.Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
2.Have open sores or open lesions in the treatment area(s).
3.Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of the product.
4.Have participated in any interventional clinical trial in the previous 90 days.
5.Have a known sensitivity to any of the constituents of the test product including sensitivities.
6. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including corticosteroids.
7. Have not skin related issues
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in skin brightness
2. Change in Skin Softness
3. Change in Skin hydration
4. Change in TEWL
5. Change in Skin discoloration
6. Change in Skin Pigmentation |
At T0mins , T30mins, Day14 and T28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SGA |
At 28days |
|
|
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)
|
18/09/2025 |
| 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="1"
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
|
A single blind one arm study. Each participant entering the trial will be assigned to a regimen of investigational product with the below assessments. - Skin Gloss by Glossymeter (T0, T30min, T14Days, T28days) - Skin Colour by Chromameter (T0, T14Days, T28days) - Skin Pigmentation by Mexameter (T0 , T14days, T28 days) - Skin Hydration with Corneometer (T0, T30min,T14days,T28days) - TEWL for moisture barrier (T0, T30min,T14days,T28days) - Dermat evaluation on a 5 point ordinal scale would be used for the blemishes (T0,T14and T28) - Dermat evaluation on a 5 point ordinal scale would be used for the pore cleanliness post dermascope (T0, T14, T28) - HD Imaging with DSLR or Visioscan (T0 and T28) - Dermascopy Images ( T0 and T28day) - Subject’s Self Assessments. (T28 only) Male
and Female with age 18-45 (80:20), Volunteers-36 Assessment Time: T0min, T+30 mins, T+14days, T+28 days |