| CTRI Number |
CTRI/2023/12/060424 [Registered on: 01/12/2023] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to determine the safety, efficacy and in-use tolerability of test treatments in healthy adult human subjects. |
|
Scientific Title of Study
|
An open-label, single-arm, single centre, interventional, prospective clinical safety, efficacy and in-use tolerability study of ThriveCo Dark Patches Corrector Cream and ThriveCo Scalp Clear Serum in healthy adult human subjects having complaint of scalp dandruff and dark patches at different body region (neck, elbows, knees, underarms) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB230036-AL Version 1.0 (Final), 09 Nov 23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| 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 |
Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Anveya Living Private Limited OLD SY No. 91/3, NEW SY NO. 91/10, Kannahalli Village, Yeshwanthapura Hobli, Bangalore, Bengaluru Rural, Karnataka - 560091 |
|
|
Primary Sponsor
|
| Name |
Anveya Living Private Limited |
| Address |
OLD SY No. 91/3, NEW SY NO. 91/10, Kannahalli Village, Yeshwanthapura Hobli, Bangalore, Bengaluru Rural, Karnataka - 560091 |
| Type of Sponsor |
Other [Manufacturer and Supplier of hair-skin beauty products]] |
|
|
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 Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj - 382421
Gandhinagar
GUJARAT
Gandhinagar
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 |
Subjects having complaint of scalp dandruff and dark patches at different body region (neck, elbows, knees, underarms) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
ThriveCo Dark Patches Corrector Cream |
Mode of Usage: Apply the cream onto desired area on your skin. Massage until it is absorbed.
Frequency: Twice a Day
Duration: 45 days
Route of Administration: Topical |
| Intervention |
ThriveCo Scalp Clear Serum |
Mode of Usage: Use 5 minutes before you wash your hair. Using the dropper, apply the serum over the scalp and massage in circular motion. Leave it on 5 minutes. Wet your hair and thoroughly wash with ThriveCo hair Vitalizing Rosemary shampoo.
Frequency: Three times in a week
Duration: 1 week
Route of Administration: Topical
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Age: 18 - 60 above (both inclusive) old at the time of consent.
2)Sex: Healthy males and non-pregnant/non-lactating females.
3)Females of childbearing potential must have a self-reported negative urine pregnancy test.
4)Subjects are generally in good general health as determined from recent medical history.
5)Subjects with mild to moderate dandruff status as per ASFS at screening.
6)Subject have unwashed and untreated scalp for 5 days.
7)Subject must have hyperpigmentation/post inflammatory hyperpigmentation/ melasma/ acanthosis nigricans.
8)The subject is willing and able to follow the study directions, participate in the study, returning for all specified visits.
9)The subject must be able to understand and provide written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1)Subject with known allergy or sensitization to test treatment ingredients.
2)History of dermatological condition of scalp other than dandruff.
3)History of alcohol or drug addiction.
4)Subject using other marketed products for dandruff control and/or dark patch removal/corrector product during the study period.
5)Subject who have plans of shaving scalp hair during the study.
6)The subject has skin irritation, open wounds, cuts, abrasions, irritation symptoms or any dermatological condition at the reading site that can interfere with the reading.
7)Medication which may affect skin and scalp response and/or past medical history.
8)Subject has any concurrent skin disease.
9)Subject has taken any systemic corticosteroids, anti-bacterial, immunosuppressant drugs in the past 30 days.
10)Subjects who undergone any laser therapies and chemical peeling.
11)Subjects who are likely to engage in activities that involve excessive exposure to sunlight.
12)Pregnant or breastfeeding or planning to become pregnant during the study period.
13)An individual who has a medical condition or is taking or has taken a medication which, in the Investigator’s judgment, makes the subject ineligible or places the subject at undue risk.
14)Subjects who have been treated with topical steroids, retinoids or other topical drugs within 2 weeks prior to entry to the study.
15)Participation in other clinical studies simultaneously.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. ThriveCo Dark Patches Corrector Cream
1.To evaluate the effectiveness of the test treatment in terms of change in dark spots| patches of the skin.
2.To evaluate the effectiveness of the test treatment in terms of change in hyperpigmentation score.
2. ThriveCo Scalp Clear Serum
1.To evaluate the effectiveness of the test treatment in terms of change in Adherent Scalp Flaking Score. |
1. ThriveCo Dark Patches Corrector Cream-
From baseline before usage of the test treatment on Day 01 and T30 mins after usage of the test treatment on Day 01, Day 21 (+2 Days) and Day 45 (+2 Days).
2. ThriveCo Scalp Clear Serum-
From baseline before usage of test treatment on Day 01 and at T30 mins after usage of the test treatment on Day 01, Day 08 (+2 Days)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of the test treatment(ThriveCo Dark Patches Corrector Cream) in terms of change in digital photographs |
From baseline before usage of the test treatment on Day 01 and T30 mins after usage of the test treatment on Day 01, Day 21 and Day 45 |
| To assess the effectiveness of the test treatment (ThriveCo Dark Patches Corrector Cream) in terms of consumer perception |
From baseline before usage of the test treatment on Day 01 and T30 mins after usage of the test treatment on Day 01, Day 21 and Day 45 |
| To evaluate the effectiveness of the test treatment (ThriveCo Scalp Clear Serum) in terms of change in scalp appearance |
From baseline before usage of test treatment on Day 01 and at T30 mins after usage of the test treatment on Day 01, Day 08. |
| To assess the effectiveness of the test treatment (ThriveCo Scalp Clear Serum) in terms of changes in scalp phototrichogram |
From baseline before usage of test treatment on Day 01 and at T30 mins after usage of the test treatment on Day 01, Day 08. |
| To assess the effectiveness of the test treatment (ThriveCo Scalp Clear Serum) in terms of consumer perception |
From baseline before usage of test treatment on Day 01 and at T30 mins after usage of the test treatment on Day 01, Day 08. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2023 |
| Date of Study Completion (India) |
15/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 open-label, single-arm, single centre, interventional, prospective clinical study to evaluate the safety, efficacy and in use tolerability of the test treatments in healthy adult human subject. A maximum of 32 subjects will enrolled to 30 subject complete the study. The adult female/male subjects will be instructed to visit the facility as per the below visits Visit 01 (Day 01): Screening Enrolment, Test Treatment Usage Period (Test Treatment A), Post Usage, Evaluations Visit 02 (Day 08+2 Days): Scalp Evaluation, End of Study (Test Treatment B) Visit 03 (Day 21+2 Days): Test Treatment Usage Period, Evaluation Phase Visit 04 (Day 45+2 Days): Evaluation Phase, End of Study (Test Treatment A)
|