| CTRI Number |
CTRI/2024/12/077682 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [safety and efficacy study] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to determine the safety and efficacy of a test products in healthy human subjects with dark circle |
|
Scientific Title of Study
|
A prospective, interventional, randomized, double-blind, four-arm, parallel, single-centre, safety, and efficacy study of dark circles corrector products in healthy adult human subjects having under eye dark circles of the vascular origin and pigment origin. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240057-CHL, Version 1.0, 12Nov24 |
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 |
Clinical trial Department NovoBliss Research Pvt Ltd office 313, Silver Radiance-4, Gota, Ahmedabad, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| 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 |
Clinical Trials department NovoBliss Research Pvt Ltd
office 313, Silver Radiance-4, Gota,
Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
09909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research private Limited |
| Address |
clinical trial department NovoBliss Research Pvt Ltd
office 313, Silver Radiance-4, Gota,
Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Chemyunion LTDA
Av Independência, 1501 - Iporanga
ZIP Code: 18087-101 - Sorocaba – SP, Brazil
|
|
|
Primary Sponsor
|
| Name |
Chemyunion LTDA |
| Address |
Chemyunion LTDA
Av Independência, 1501 - Iporanga
ZIP Code: 18087-101 - Sorocaba – SP, Brazil
|
| Type of Sponsor |
Other [Pharmaceutical Chemical ] |
|
|
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 Pvt. Limited |
Clinical trial Department NovoBliss Research Pvt Ltd
office 313, Silver Radiance-4, Gota,
Ahmedabad, India - 382481.
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 |
Subjects with dark circle |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Benchmark |
Route of Administration :Topical Mode of Application :The product must be applied in the region around the eyes, where dark circles form, the amount used is one "pump" that must be applied with the fingertips by massaging the region, until the whitish appearance is reduced, avoiding spread the product beyond the region of interest. Frequency: Twice a Day
Duration: 28 days
Dosage Form: cream |
| Intervention |
Benchmark + Test Sample |
Route of Administration :Topical
Mode of Application :The product must be applied in the region around the eyes, where dark circles form, the amount used is one "pump" that must be applied with the fingertips by massaging the region, until the whitish appearance is reduced, avoiding spread the product beyond the region of interest.
Frequency: Twice a Day
Duration: 28 days
Dosage Form: cream |
| Comparator Agent |
Placebo |
Route of Administration :Topical Mode of Application :The product must be applied in the region around the eyes, where dark circles form, the amount used is one "pump" that must be applied with the fingertips by massaging the region, until the whitish appearance is reduced, avoiding spread the product beyond the region of interest. Frequency: Twice a Day
Duration: 28 days
Dosage Form: cream |
| Intervention |
Test Sample |
Route of Administration :Topical
Mode of Application :The product must be applied in the region around the eyes, where dark circles form, the amount used is one "pump" that must be applied with the fingertips by massaging the region, until the whitish appearance is reduced, avoiding spread the product
Duration: 28 days
Dosage Form: cream |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age: 20 to 45 years (both inclusive) at the time of consent. (preferably 30 to 45 years).
Sex: Healthy male and non-pregnant/non-lactating females.
Females of childbearing potential must have a self-reported negative pregnancy test.
Subject are generally in good health.
Subject having undereye dark circles of vascular origin and pigment origin based on
dermatological assessment.
Subject agreed to not to use any other eye care throughout the study period.
Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
If the subject is of childbearing potential, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with
spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been postmenopausal for at least 1 year or have had a tubal ligation.
Subjects are willing to give written informed consent and are willing to come for regular follow up.
Subjects who commit not to use medicated skincare products other than the test product for the entire duration of the study.
Subject who have not participated in a similar investigation in the past three months.
Willing to use test product throughout the study period |
|
| ExclusionCriteria |
| Details |
Subjects must not be enrolled in the study if they meet any one of the following criteria:
History of any dermatological condition of the skin diseases.
Subject with present condition of allergic response to any cosmetic product.
Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, antihistamines, corticotherapy etc.) that might influence the outcome of the study.
Subjects who have applied topical treatment for at least 4 weeks and any systemic
treatment for at least 3 months, before they participated in the study.
History of alcohol or drug addiction.
Subjects using other marketed products during the study period.
Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
Pregnant or breastfeeding or planning to become pregnant during the study period.
History of chronic illness which may influence the cutaneous state.
Subjects participating in other similar cosmetics, devices or therapeutic trials or skincare
products within the last four weeks. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test product in terms of
1.change in L, a, b and ITA by using the skin colorimeter Flex CL 400
2. change in erythema and melanin level by using the Mexameter MX 18.
|
Before product usage on Day 01 and after usage of the test products on Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effectiveness of the test products in terms of
1. visible change in dark circles through the image analysis
2.visual change in dark circles by dermatological assessment
3. subjective product perception using 9-point hedonic scale |
Before product usage on Day 01 and after usage of the test products on Day 28 |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
|
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
|
A prospective, interventional, randomized, double-blind, four-arm, parallel, single-centre, safety, and efficacy study of dark circles corrector products in healthy adult human subjects having under eye dark circles of the vascular origin and pigment origin There will be total of 3 visits Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation Visit 02 (Day 15): Telephonic follow-up evaluation Visit 03 (Day 28 +2 Days): Evaluations, End of the study A total of 88 Subjects will be enrolled to complete 80 Subjects the study. |