| CTRI Number |
CTRI/2025/02/080048 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to assess the safety and effectiveness of two test products in subjects having dark spots, acne spots, sunspots, and age spots. |
|
Scientific Title of Study
|
An Exploratory, Evaluator-Blinded, Randomized, Interventional, Prospective Proof-of-Concept Study to Assess the Safety and Efficacy of Two Test Products in Female Subjects having Dark Spots, Acne Spots, Sunspots, Age Spots on their face. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240066-SH Version 1.0 22Jan25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota, Ahmadabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota, Ahmadabad
GUJARAT
382481
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari N Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota, Ahmadabad
Ahmadabad
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Keva – 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- 400080 Maharashtra - India |
| Type of Sponsor |
Other [Manufacturer - Cosmetics] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
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 Nayan Patel |
NovoBliss Research Private Limited |
NovoBliss Research Pvt. Ltd. Office# 313, Silver Radiance-4, Gota, Ahmadabad
Ahmadabad
GUJARAT |
9909013286
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 |
Healthy Human Adults having dark spots, age spots, sunspots, acne spots |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Test Product A: Face Cream
|
Dose: 0.6 gm
dosage form: cream
Route of administration: Topical
Frequency: Twice a Day
Mode of Usage: Apply a Coin sized (Approx. 0.6gm, coin size) amount of the test product to the face and gently massage it until fully absorbed.
Duration: 60 Days |
| Intervention |
test product B: Face Gel Cream |
Dose: 0.6 gm
Dosage Form: Serum
Frequency: Twice a Day
Mode of Usage: Apply a Coin sized amount (Approx. 0.6gm, coin size) of the test product to the face and gently massage it until fully absorbed.
Route of Administration: Topical
Duration: 60 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1)Age: 18 to 55 years (both inclusive) 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, 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.
10)Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the effectiveness of the test products in terms of change in skin color (L, a, b and ITA) using skin colorimeter flex CL 400 from baseline before usage of the test products and after usage of the test products and between the test product
2.To evaluate the effectiveness of the test products in terms of change in skin erythema and melanin using Mexameter MX 18 from baseline before usage of the test products and after usage of the test products and between the test product.
3.To evaluate the effectiveness of the test products in terms of change in skin texture i.e. skin roughness, smoothness, scaliness, wrinkles and finelines using VISIOSCAN VC 20 Plus from baseline before usage of the test products and after usage of the test products and between the test product. |
On day 1, day 30 and day 60. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effectiveness of the test products in terms of changes in skin hyperpigmentation from baseline before usage and after usage of the test products, and between test products by using scoring scale.
|
On day 1, day 30 and day 60. |
| 2. evaluate the effectiveness of the test products in terms of changes in Glogau skin age classification from baseline before usage and after usage of the test products, and between test products by using scoring scale. |
On day 1, day 30 and day 60. |
| 3. evaluate the effectiveness of the test products in terms of subjective product perception and non-comedogenic questionnaire assessment by using scoring scale |
On day 1, day 30 and day 60. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="17" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2025 |
| Date of Study Completion (India) |
25/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This is an exploratory, evaluator-blinded, randomized, interventional, prospective proof-of-concept study to assess the safety and efficacy of two test products in female subjects having dark spots, acne spots, sunspots, age spots on their face. A total of 34 non-pregnant, non-lactating females (17 females/product) aged 18 to 55 years (inclusive), will be enrolled to ensure that 30 subjects (15 females/product) complete the study. Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation. Visit 02 (Day 30 +2 Days): Test Products Usage, Evaluations. Visit 03 (Day 60 +2 Days): Final Evaluation, End of Study. |