| CTRI Number |
CTRI/2024/07/070860 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [safety and efficacy study] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to assess the safety and effectiveness of test products in healthy adult human subjects having hair fall complaints.
|
|
Scientific Title of Study
|
A prospective, interventional, open-label, non-randomized, two-arm, parallel, clinical safety, efficacy and in-use tolerability study of the two
test products in healthy adult human subjects having hair fall complaints (alopecia i.e. more than 100 hairs fall per day). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240035-PT version 1.0 02 Jul 24 |
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,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar
GUJARAT
382421
India |
| Phone |
7948983895 |
| 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,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar
GUJARAT
382421
India |
| Phone |
7948983895 |
| 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,
Nr. Vaishnodevi Circle, Khoraj,
Gandhinagar
GUJARAT
382421
India |
| Phone |
9909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Soulflower – PT INVENT INDIA PVT LTD
Soulflower| Compartment No 56,
Plot No 10/12,
Marol Industrial Co-Op. Society,
Sag Baug, Near Shemaroo,
Entertainment, Andheri East,
Mumbai 400059 |
|
|
Primary Sponsor
|
| Name |
Soulflower – PT INVENT INDIA PVT LTD |
| Address |
Soulflower| Compartment No 56,
Plot No 10/12,
Marol Industrial Co-Op. Society,
Sag Baug, Near Shemaroo,
Entertainment, Andheri East,
Mumbai 400059 |
| Type of Sponsor |
Other [Beauty and Personal care] |
|
|
Details of Secondary Sponsor
|
|
|
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 – 382421,
Gujarat – India
Gandhinagar
GUJARAT |
7948983895
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: L639||Alopecia areata, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Soulflower Rosemary Essential Oil
|
Test Product : Soulflower Rosemary Essential Oil
Marketed By: Soulflower – PT INVENT INDIA PVT LTD
Mode of Usage: Mix 5 drops of the oil with 1 tablespoon (approximately 15
mL) of Soulflower castor oil. Divide the hair into sections and apply the
mixture directly to scalp using your fingertips or a dropper. Gently massage
your scalp for 5-10 minutes to enhance blood circulation. Leave the oil on
your scalp for 4 hours or overnight for better results, then rinse
your hair with a mild shampoo and warm water.
Frequency: Apply for 3 days weekly
Route of Administration: Topical
Dose :15ml
Dosage form: Hair oil
Total Duration: 90 Days
|
| Intervention |
Soulflower Rosemary Lavender Hair Oil |
Test Product : Soulflower Rosemary Lavender Healthy Hair Oil. Marketed By: Soulflower – PT INVENT INDIA PVT LTD Mode of Usage: Divide the hair into sections and apply the approx. 15mL of rosemary lavender oil directly to scalp using your fingertips or a dropper. Gently massage your scalp for 5-10 minutes to enhance blood circulation. Leave the oil for 4 hours or overnight for better results, then rinse your hair with a mild shampoo and warm water. Frequency: Apply for 3 days weekly Route of Administration: Topical.
Dose: 15ml
Dosage: hair oil
Total Duration: 90 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Age: 18 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 more than 100 hair fall per day.
6) Subject with self-assessed complaint of thinning of hair.
7) 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.
8) 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.
9) 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.
10) Subjects are willing to give written informed consent and are willing to follow the study
procedure.
11) 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.
12) Willing to use test product throughout the study period |
|
| ExclusionCriteria |
| Details |
1) History of any dermatological condition of the scalp other than hair loss.
2) History of prior use of hair growth treatment within 3 months.
3) History of any prior hair growth procedures (e.g., hair transplant or laser).
4) 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.
5) Subject who perform any salon treatment on hair including haircut during the study period.
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test products in terms of
1.change in hair growth rate from baseline before and after usage of the test
products.
2. change in hair density, hair thickness from baseline before and after usage of the
test products.
3.change in hair length from baseline before and after usage of the test products.
4. change in hair fall reduction from baseline before and after usage of the test products. |
Day 04 before Day 01, Day 01, and after test product usage on Day 45, Day 87 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of the test products in terms of
1.change in hair root strength and scalp condition and A:T ratio.
2.change in general appearance of the hair and scalp
3. subject perception questionnaire. |
Day 04 before Day 01, Day 01, and after test product usage on Day 45, Day 87 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/07/2024 |
| 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="3"
Days="0" |
|
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
|
This is prospective, interventional, open-label, non-randomized, two-arm, parallel, clinical safety, efficacy and in-use tolerability study the test products in healthy adult human subjects having hair fall complaints. A total of 60Subjects (30 subjects/arm) healthy adult male and non-pregnant |non-lactating females will be enrolled the study. The total duration of the study will be 90 days from the enrolment. Visit 01 (Day -04)Screening, tattoo creation and hair growth rate measurement Visit 02 (Day 01)Enrolment, Baseline evaluation Visit 03 (Day 45 +2 Days)product usage period and evaluations Visit 04 (Day 87 +2 Days)Tattoo creation and Evaluations Visit 05 [Day 90]Evaluation and End of study |