| CTRI Number |
CTRI/2025/09/095314 [Registered on: 23/09/2025] 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
|
Check efficacy of Niacinamide Serum for skin pigmentation and gloss |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of Niacinamide Serum for skin pigmentation and gloss |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CCFT837 Version 1.0 dated 8 sept 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
|
| CCFT Laboratories, Mittal Group Building, 121-B Mansarovar Industrial Estate, Panchli, Baghpat Road, Meerut, UTTAR PRADESH-250005 |
| UAS Pharmaceuticals Pty Ltd, 43/10 Gladstone Road, castle hill,NSW 2154, Australia |
|
|
Primary Sponsor
|
| Name |
UAS Pharmaceuticals Pty Ltd |
| Address |
43/10 Gladstone Road, castle hill,NSW 2154, Australia |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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: Niacinamide Serum |
Dose: Gently use the Niacinamide serum on the face twice a day for 4 weeks.
Route of Administration: Topical |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1) Gender: Male or Female with age 18-45
2) Subjects with oily skin , have hyperpigmentation .
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. Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
2. Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
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
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 Gloss
2. change in Skin Pigmentation 3. change in Skin Hydration
4. change in Dark Spots
5. change in Sebum
6. Wrinkles by Visioface
7. Dermate evaluation
8. HD Imaging with DSLR |
Time points AtT0, day 14 and day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
06/10/2025 |
| 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
|
An open label one arm study.
Each participant entering the trial will be assigned to a regimen of
investigational product with the below assessments. Product to be
applied at face and neck both.
- Skin Gloss by Glossymeter (T0, day 14 and day 28 ) - Skin Pigmentation by Mexameter Face (Melanin Index) (Day 0,
14, 28) - Skin Hydration by Corneometer (T0, day14 and day 28) - Dark Spots by Visioface (Day 0, 14, 28) - Sebum by Sebumeter ( Day 0,14,28) - Wrinkles by Visioface ( Day 0,14,28) - Skin Barrier by TEWAMETER (Day 0,14,28) - Dermat evaluation on a 5-point ordinal scale would be used for the
Even Skin Tone (Day 0, 14,28) - Dermat evaluation on a 5-point ordinal scale would be used for the
Skin Texture (Day 0, 14,28) - Dermat evaluation on a 5-point ordinal scale would be used for the
Smooth skin (Day 0, 14,28) - Visioscan Images Day 0, and Day 28 - HD Imaging with DSLR (Day 0 and Day 28 ) - Subject’s Self Assessments. (day 28 )
Test Product: Niacinamide Serum
Dose: Gently use the Niacinamide serum on the face twice a day
for 4 weeks.
Route of Administration: Topical Subjects will be on study for up to 28 days.
Screening & Assigning: Day 1
Follow-ups: on Day 1-30min, and Day 14
EOT: Day 28
|