| CTRI Number |
CTRI/2024/02/062972 [Registered on: 21/02/2024] 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 Assess the Safety and efficacy of test product. |
|
Scientific Title of Study
|
An Open-Label, Non-Randomized, Single-Arm, Single-Centre, Prospective, Interventional, Safety, Efficacy and Tolerability Study of Hair Growth and Anti-Gray Hair Serum in Healthy Adult Females with Partially Gray Hairs and Hair Fall Complaints. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240006-PT_Version_(1.0)_05Feb24 |
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 |
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 |
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 |
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
|
| Soulflower Sanctuary | 10/12, Marol Co-operative Industrial Estate,
Marol, Andheri East, Mumbai 400059,
Maharashtra, India
|
|
|
Primary Sponsor
|
| Name |
Soulflower PT INVENT INDIA PVT LTD |
| Address |
Soulflower Sanctuary | 10/12, Marol Co-operative Industrial Estate,
Marol, Andheri East, Mumbai 400059,
Maharashtra, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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
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 |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hair Growth and Anti-Gray Hair Serum |
Name: Hair Growth and Anti-Gray Hair Serum
Marketed By:Soulflower – PT INVENT INDIA PVT LTD
Mode of usage:Spray the serum directly on clean scalp & massage thoroughly. Do not rinse, style as usual.
Frequency: Once a Day(Evening)
Route of Administration: Topical
Duration: 120 Days
Dose: 1 to 2 ml or as required |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1)Age: 20 to 55 years (both inclusive) at the time of consent.
2)Sex: Healthy non-pregnant/non-lactating females.
3)Females of childbearing potential must have a self-reported negative pregnancy test.
4)Subject are generally in good health.
5)Subject with partially gray hair.
6)Subject with low hair growth and complaint of hair fall.
7)Subject with self-assessed complaint of thinning of hair.
8)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.
9)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.
10)If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
11)Subjects are willing to give written informed consent and are willing to follow the study procedure.
12)Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil), any other hair growth hair products or hair colour or dye, other than the test products for the entire duration of the study.
13)Willing to use test product throughout the study period.
|
|
| ExclusionCriteria |
| Details |
1)Subjects with any other hair colour except gray.
2)History of any dermatological condition of the scalp other than hair loss and/or dandruff.
3)History of prior use of hair growth treatment within 3 months.
4)History of any prior hair growth procedures (e.g., hair transplant or laser).
5)Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
6)History of alcohol or drug addiction.
7)Subjects using other marketed hair fall control and/or hair growth products during the study period.
8)Subjects who have plans of shaving scalp hair during the study
9)Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
10)History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
11)Subjects having a history or present condition of an allergic response to any cosmetic products.
12)Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
13)Pregnant or breastfeeding or planning to become pregnant during the study period.
14)History of chronic illness which may influence the cutaneous state.
15)Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp care products within the last four weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the hair growth on the scalp using CASLite Nova.
2.To assess the effectiveness of the test product in terms of change in A:T ratio using Phototrichogram.
3. To assess the effectiveness of the test product in terms of change in hair density and hair thickness using CASLite Nova.
4. To assess the effectiveness of the test product in terms of change in hair fall using 60 sec hair comb test.
5. To assess the effectiveness of the test product in terms of change in graying severity score by dermetologidt trained scorer and dermatologist. |
1.For hair growth on the scalp from (Day -04) before test product usage and after product usage on Day 01, Day 87, Day 90.
2.For other parameters from baseline before usage Day 01 and on Day 45 ,Day 90 and Day 120 post product usage. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To assess the effect of the test product in terms of scalp skin appearance i.e. itchiness, redness, roughness and scaliness of scalp evaluated by dermatologist trained evaluator or dermatologist. |
From baseline on day 01 before test product usage and on day 45, day 90 and day 120 post product usage. |
| 2.To assess the consumer perception about product using subjective questionnaire |
Before usage Day 01 and on day 45 ,day 90 and day 120 post product usage. |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/03/2024 |
| Date of Study Completion (India) |
08/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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, Non-Randomized, Single-Arm, Prospective, Interventional, Safety, Tolerability and Efficacy Study of Hair Growth and Anti-Gray Hair Serum in Healthy Adult Females with Partially Gray Hairs and Hair Fall Complaints.
A total up to 32 healthy adult non-pregnant/non-lactating females with the age of 20-55 years, with partially grey hairs and hair fall complaints will be enrolled to ensure a total of 30 subjects complete the study.
Subjects will be instructed to visit the facility as per the below visit. Visit 01 (Day -04) Screening Visit 02 (Day 01) Enrolment and Baseline Readings Visit 03 (Day 45) Test Product Usage Phase, Evaluations Visit 04 (Day 87) Test Product Usage Phase, Tattoo and Hair Growth Measurement Visit 05 (Day 90) Test Product Usage Phase, Evaluation Visit 06 (Day 120) End of Visit, Test Product Usage Phase, Evaluations |