| CTRI Number |
CTRI/2026/01/100492 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to assess the safety and effectiveness of skin brightening face oil in subjects having dark spots, acne spots, sunspots, and age spots |
|
Scientific Title of Study
|
An Exploratory, Open Label, Interventional, Prospective, Proof-of-Concept Clinical Study to Assess the Safety and Efficacy of Test Product in Female Subjects having Dark Spots, Acne Spots, Sunspots, Age Spots on their face |
| Trial Acronym |
FADES |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250058-SH, Version 1.0, 31 Dec 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Apeksha Merja |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India -
Ahmadabad
GUJARAT
382481
India
Ahmadabad
GUJARAT
09909013286
India |
| Phone |
|
| Fax |
|
| Email |
consultant@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Sub Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India -
Ahmadabad
GUJARAT
382481
India
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India -
Ahmadabad
GUJARAT
382481
India
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| S H Kelkar and Company Limited LBS Marg, Mulund (West), Mumbai – 400 080, India |
|
|
Primary Sponsor
|
| Name |
S H Kelkar and Company Limited |
| Address |
LBS Marg, Mulund (West), Mumbai – 400 080, India |
| Type of Sponsor |
Other [Cosmetics Products Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
NovoBliss Research Private Limited |
313, Clinical operations Department, NovoBliss Research Private Limited
Ahmadabad
GUJARAT |
09909013286
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Human volunteers having dark spots, acne spots, sunspots, and age spots |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Skin Brightening Face Oil |
Mode of Usage: Apply 4-5 drops of the product on face and massage gently in circular motion and upward direction
Frequency: Twice Daily
Total Duration: 60 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 18 to 55 years at the time of consent.
2) Sex: Adults female subjects having dark spots/pigmentation caused by acne spots, sunspots age spots.
3) Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
4) Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin pigmentation in last 6 months.
5) Subjects must be willing to stop using any cosmetics or any medical products for skin pigmentation for the duration of the study.
6) Subjects are not allowed to participate in any other study until this study is complete.
7) Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
8) Subjects must agree to record each use of the test products in the subject’s diary card on daily basis.
9) Subjects must agree to record medication use during the study.
|
|
| ExclusionCriteria |
| Details |
1) Subjects who are on steroids for last six months.
2) Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last six months.
3) Subjects with other dermatologic diseases whose presence or treatments could interfere with the assessment of study.
4) Subjects that are pregnant and/or breastfeeding.
5) The subject has a known allergy or sensitivity to soaps, lotions, detergents, detanglers or fragrances.
6) Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.
7) The subject has any other skin conditions i.e. cuts, scratches, active acne, ring worms, etc. which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
8) The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results.
9) The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the effectiveness of the test product in terms of change in skin erythema and melanin from baseline before usage and after usage of the test product.
2.To evaluate the effectiveness of the test product in terms of change in in skin color parameters from baseline before usage and after usage of the test product.
|
Day 01, Day 30 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the effectiveness of test product in terms of reduction in dark spots from baseline before and after usage of the test product.
2.To evaluate the effectiveness of test product in terms of change in comedones from baseline before and after usage of the test product.
3.To evaluate the effectiveness of test product in terms of change in skin brightness from baseline before and after usage of the test product.
4.To evaluate the effectiveness of test product in terms of change in facial appearance from baseline and after usage of the test product.
5.To evaluate the effectiveness of the test product in terms of subjective product perception regarding the test product’s effect on dark spots reduction, appearance, radiance, acne or skin breakouts, glowing skin tone, blemishes and dark skin patches reduction from baseline before usage and after usage of the test product
|
Day 01, Day 30 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="2"
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
|
This exploratory, open-label, interventional,
prospective, proof-of-concept clinical study to assess the safety and efficacy
of test product in female subjects having dark spots, acne spots, sunspots, age
spots on their face.
A total of 33
non-pregnant, non-lactating females aged 18 to 55 years (inclusive), will be
enrolled to complete the study. The subjects will be
instructed to visit the facility as per the below visits. Visit 01: Screening Visit 02
(Day 01): Enrolment, Baseline Evaluation Visit 03
(Day 30 +2 Days): Test Product Usage, Evaluations Visit 04
(Day 60 +2 Days): Final Evaluation, End of Study |