| CTRI Number |
CTRI/2024/01/061138 [Registered on: 05/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| 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 evaluate the safety, efficacy and in-use tolerability of two different 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 Scar Fader Gel and ThriveCo Bumps Eraser Kit (ThriveCo Bumps Eraser Exfoliating Scrub and ThriveCo Smoothing Body Lotion). |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB230035-AL Version 1.0(Final),29 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 |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj.
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 |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. 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 |
NovoBliss Research Pvt. Ltd.
Office# A - 206, 2nd Floor,
Shaligram Lakeview Business Complex,
Nr. Vaishnodevi Circle, Khoraj.
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,
Nr. 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 |
Having scars and bumpes on their skin |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
ThriveCo Bumps Eraser Kit (1. ThriveCo Bumps Eraser Exfoliating Scrub 2, ThriveCo Smoothing Body Lotion) |
1)ThriveCo Bumps Eraser Exfoliating Scrub
Mode of Usage:Wet the skin, massage the test treatment in circular motion for 3-4 mins and wash off with water followed by application of ThriveCo Smoothing Body Lotion.
Frequency:Three times a week.
Total Duration: 45 days
Route of Administration: Topical
Dosage form: Scrub
Dose: Required amount
2)ThriveCo Smoothing Body Lotion
Mode of Usage:Apply to clean, dry skin all over body or problem areas. Massage till fully absorbed.
Frequency: Daily
Total Duration: 45 days
Route of Administration: Topical
Dosage form: Lotion
Dose: Required amount
|
| Intervention |
ThriveCo Scar Fader Gel |
Mode of Usage: Wash and pat dry the scar area, apply a thin layer of gel on the affected area. Massage gently until the product is absorbed.
Frequency: Use it twice daily.
Total Duration: 45 days
Route of Administration: Topical application.
Dosage form: Gel
Dose: Adequate amount |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1)Age: 18 to 60 years (both inclusive) at the time of consent.
2)Sex: Healthy non-pregnant/non-lactating females.
3)Subject are generally in good health as determined by/form recent medical history.
4)Subject must have scars (acne scar, hypertrophic scar) on their skin.
5)Subjects with keratosis pilaris/ strawberry legs/ extremely dry skin.
6)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.
7)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 post-menopausal for at least 1 year or have had a tubal ligation.
8)Subjects are willing to give written informed consent and are willing to follow the study procedure.
9)Subjects who commit not to use medicated/ prescription products for scar and bumpy skin other than the test treatments for the entire duration of the study.
10)Willing to use test treatments throughout the study period. |
|
| ExclusionCriteria |
| Details |
1)Subjects having active infection at site of scars or bumpy skin site.
2)Subject with history of dermatological condition or active dermatological condition.
3)Subject with known allergy or sensitivity to the ingredients of test treatments.
4)Subject has used any systemic therapy with chronic antibiotic therapy, retinoids, and/or oral steroids during the 4 weeks prior to the start or anticipates having to use at any point during the study.
5)Subject has applied any topical retinoids within 2 weeks of the screening visit or anticipates having to use at any point during the study.
6)Subject is currently pregnant/breastfeeding.
7)Subject has a history of any prior scar treatment procedures (e.g., radiofrequency therapy or laser therapy).
8)Subject has a history of alcohol or drug addiction.
9)Subject having any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
10)Subject planning to become pregnant during the study period.
11)Subject with history of chronic illness which may influence the cutaneous state.
12)Subjects participating in other similar trials within the last four weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)ThriveCo Scar Fader Gel
1.To assess the effectiveness of the test treatment in terms of visible change in scar.
2)ThriveCo Bumps Eraser Kit
1.To assess the effectiveness of the test treatment in terms of change in skin hydration
2.To assess the effectiveness of test treatment in terms of change in in the skin redness and pigmentation.
3.To assess the effectiveness of the test treatment in terms of change in skin itchiness. |
1)ThriveCo Scar Fader Gel
From baseline before usage of test treatment on Day 01 and after usage of test treatment on Day 21(+2 Days) and Day 45(+2 Days).
2)ThriveCo Bumps Eraser Kit
From baseline before usage of test treatment on Day 01 and after usage of test treatment at T30 mins on Day 01, Day 21(+2 Days) and Day 45(+2 Days). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To assess the effectiveness of the test treatment(ThriveCo Scar Fader Gel )in terms of change in skin texture. |
From baseline before usage of test treatment on Day 01 and after usage of test treatment on Day 21 and Day 45. |
| 2.To assess the effectiveness of the test treatment(ThriveCo Scar Fader Gel)in terms of change in digital photographs of the scar. |
From baseline before usage of the test treatment on Day 01 and after usage of test treatment on Day 21 and Day 45. |
| 3. To assess the effectiveness of the test treatment(ThriveCo Scar Fader Gel)in terms of treatment perception. |
From baseline before usage of the test treatment on Day 01 and after usage of test treatment on Day 21 and Day 45. |
| 4.To assess the effectiveness of the test treatment(ThriveCo Bumps Eraser Kit) in terms of change in skin texture i.e. smoothness, roughness, scaliness. |
From baseline before usage of test treatment on Day 01 and after usage of test treatment at T30 mins on Day 01, Day 21and Day 45. |
| 5.To assess the effectiveness of the test treatment(ThriveCo Bumps Eraser Kit)in terms of change in digital photographs. |
From baseline before usage of the test treatment on Day 01 and after usage of test treatment at T30 mins on Day 01, Day 21 and Day 45. |
| 6.To assess the effectiveness of the test treatment(ThriveCo Bumps Eraser Kit) in terms of treatment perception after usage of the test treatment. |
From baseline before usage of the test treatment on Day 01 and after usage of test treatment at T30 mins, Day 21and Day 45. |
|
|
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)
|
12/01/2024 |
| 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="1"
Days="15" |
|
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
|
An open-label, single-arm, single centre, interventional, prospective, clinical safety, efficacy and in-use tolerability study of ThriveCo Scar Fader Gel and ThriveCo Bumps Eraser Kit (ThriveCo Bumps Eraser Exfoliating Scrub and ThriveCo Smoothing Body Lotion).
32 adult female subjects will be recruited/enrolled to ensure a total of 30 subjects complete the study.
Subjects will be instructed to visit the facility as per the below visits.
Visit 01 (Day 01): Screening and Enrollment Visit 02 ( Day 21 + 2 Days): Test Treatment Usage Period, Evaluations Visit 03 (Day 45 + 2 Days) : Evaluations, End of Study |