| CTRI Number |
CTRI/2023/11/060289 [Registered on: 28/11/2023] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety and Efficacy of Cosmetic Products] |
| 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 Scalp Kit (ThriveCo Exfoliating Scalp Scrub and ThriveCo Scalp Vitalizing Serum) and ThriveCo Acne Kit (ThriveCo Acne Cleanser and ThriveCo Acne Serum) in healthy adult human subjects having complaint of scalp dandruff and facial acne. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB230034-AL Version 1.0 (Final), 02 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 |
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 facial acne |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
ThriveCo Acne kit
(1. ThriveCo Acne Cleanser
2. ThriveCo Acne Serum) |
1. ThriveCo Acne Cleanser
Mode of Usage:Squeeze a coin sized amount on your palm. Gently massage in circular motions for 1-2 mins. Wash off with water.
Frequency: Twice a Day
Total Duration: 15 Days
Route of Administration: Topical
Dosage Form: Acne Cleanser
2. ThriveCo Acne Serum
Mode of Usage: Start with a freshly cleansed face, massage 2-3 drop of acne serum onto the face and neck.
Frequency: Twice a Day
Total Duration: 15 Days
Route of Administration: Topical
Dosage Form: Acne Serum |
| Intervention |
ThriveCo Scalp Kit
(1. ThriveCo Exfoliating Scalp Scrub
2. ThriveCo Scalp Vitalizing Serum ) |
1. ThriveCo Exfoliating Scalp
Mode Of Usage: Apply the scrub on dry scalp and massage into your roots. Leave it on for utmost 10 minutes before rinsing thoroughly.
Frequency: 2 times a week
Total Duration: 15 Days
Route of Administration: Topical
Dosage Form: Scalp Scrub
2. ThriveCo Scalp Vitalizing Serum
Mode of Usage: Section your hair and apply evenly across the scalp using the dropper. Massage in with fingertips. Use on damp or dry hair. Do not rinse out.
Frequency: Daily
Total Duration: 15 Days
Route of Administration: Topical
Dosage Form: Scalp Serum |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Age: 18 - 50 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 mild to moderate acne on their skin (IGA score 2 to 3).
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 acne and dandruff control and/or hair growth products 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 on the face that can interfere with the reading.
7)Be wearing any facial makeup on the day of the study visit.
8)Medication which may affect skin and scalp response and/or past medical history.
9)Subject has any concurrent skin disease.
10)Subject has taken any systemic corticosteroids, anti-bacterial, immunosuppressant drugs or abradant facial procedures in the past 30 days.
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 Scalp Kit
1) To assess the effectiveness of the test treatment in terms of change in Adherent Scalp Flaking Score.
2) To assess the effectiveness of the test treatment in terms change in hair thickness, hair density and scalp condition.
3) To assess the effectiveness of the test treatment in terms of change in scalp skin hydration
2. ThriveCo Acne Kit
1) To assess the effectiveness of the test treatment in terms of change in inflammatory and non-inflammatory lesion.
2) To assess the effectiveness of the test treatment in terms of change in skin hydration.
3) To assess the effectiveness of the test treatment in terms of change in skin sebum level.
4) To assess the effectiveness of the test treatment in terms of change in facial dark spot i.e. blemishes |
1. ThriveCo Scalp Kit
From baseline before usage of the test treatment on Day 01 and T60 mins after usage of the test treatment on Day 01, Day 08 (+2 Days) and Day 15 (+2 Days)
2. ThriveCo Acne Kit
from baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08(+2 Days), and Day 15 (+2 Days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To assess the effect of the test treatment(Scalp Kit) in terms of change in scalp appearance i.e. dryness, itchiness, redness, and scaliness |
From Baseline before usage of the test treatment on Day 01 and after usage of the test treatment on Day 01, Day day 08 and Day 15 |
| 2.To assess the effect of the test treatment(Scalp Kit) in terms of change in scalp photographs using CASLite Nova |
From Baseline before usage of the test treatment on Day 01 and after usage of the test treatment on Day 01, Day day 08 and Day 15 |
| 3.To assess the effect of the test treatment (Scalp Kit) in terms of treatment perception questionnaire using 9-point hedonic scale |
After usage of the test treatment on Day 01, Day day 08 and Day 15 |
| 4. To assess the effectiveness of the test treatment (Acne kit) in terms of change in acne severity using IGA scale |
From baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08, and Day 15. |
| 5.To assess the effectiveness of the test treatment (Acne Kit) in terms of change in facial photographs (left/right/center) |
From baseline before usage of test treatment on Day 01 and T15 mins after usage of the test treatment on Day 01, Day 08, and Day 15 |
| 6. To assess the effectiveness of the test treatments (Acne Kit) in terms of treatment perception questionnaire using 9-point hedonic scale |
After usage of the test treatment on Day 01, Day day 08 and Day 15 |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/12/2023 |
| Date of Study Completion (India) |
30/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
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 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. subjects will be instructed to visit the facility as per the below visits. Visit 01 (Day 01): screening, Enrolment, Test Treatment Usage Period, Post Usage 1st Wash, Evaluation Visit 02 (Day 08): Evaluation Phase, Test Treatment Usage Period Visit 03 (Day 15): Test Treatment Usage Period, End of the Study |