| CTRI Number |
CTRI/2024/11/076381 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Safety, Efficacy Study] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to determine the safety and efficacy of a test products in healthy human subjects with grey (mild to moderate grey hairs) and hair fall complaints. |
|
Scientific Title of Study
|
Proof-of-concept, Single-Blinded, Randomized, Interventional, Prospective, In-Use Safety, Tolerability and Efficacy Study of Anti-Grey Hair and Hair Growth Effect of Test Products. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB240041-CHL, 1.0, 22 Oct 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator |
| 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 |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt Ltd
Office#A-206, 2nd Floor
Shaligram Lakeview Business Complex
Nr. Vaishnodevi Circle, Khoraj
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 |
9909013286 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Chemyunion LTDA
Av Independência, 1501 - Iporanga Av Independência, 1501 - Iporanga
|
|
|
Primary Sponsor
|
| Name |
Chemyunion LTDA |
| Address |
Av Independência, 1501 - Iporanga Av Independência, 1501 - Iporanga
ZIP Code: 18087-101 - Sorocaba – SP, Brazil |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
NovoBliss Research Pvt Ltd
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 |
| Healthy Human Volunteers |
Hair fall complaints and grey hairs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hair Tonic 1 |
Route of Administration: Topical
Mode of Application : A sufficient quantity of hair tonic can be applied only in the scalp area. The product can be distributed throughout the scalp, near the root, not along the hair. Do not apply to the eye area or swallow the product.
Once applied to the scalp, performing a soft circular massage (1 minute) with the fingertips is important to facilitate its total absorption.
Frequency: Two times a day
|
| Intervention |
Hair Tonic 2 |
Route of Administration: Topical
Mode of Application : A sufficient quantity of hair tonic can be applied only in the scalp area. The product can be distributed throughout the scalp, near the root, not along the hair. Do not apply to the eye area or swallow the product.
Once applied to the scalp, performing a soft circular massage (1 minute) with the fingertips is important to facilitate its total absorption.
Frequency: Two times a day
|
| Intervention |
Hair Tonic 3 |
Route of Administration: Topical
Mode of Application : A sufficient quantity of hair tonic can be applied only in the scalp area. The product can be distributed throughout the scalp, near the root, not along the hair. Do not apply to the eye area or swallow the product.
Once applied to the scalp, performing a soft circular massage (1 minute) with the fingertips is important to facilitate its total absorption.
Frequency: Two times a day |
| Intervention |
Hair Tonic 4 |
Route of Administration: Topical
Mode of Application : A sufficient quantity of hair tonic can be applied only in the scalp area. The product can be distributed throughout the scalp, near the root, not along the hair. Do not apply to the eye area or swallow the product.
Once applied to the scalp, performing a soft circular massage (1 minute) with the fingertips is important to facilitate its total absorption.
Frequency: Two times a day |
| Intervention |
Hair Tonic 5 |
Route of Administration: Topical
Mode of Application : A sufficient quantity of hair tonic can be applied only in the scalp area. The product can be distributed throughout the scalp, near the root, not along the hair. Do not apply to the eye area or swallow the product.
Once applied to the scalp, performing a soft circular massage (1 minute) with the fingertips is important to facilitate its total absorption.
Frequency: Two times a day |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Age: 20 to 55 years (both inclusive) at the time of consent.
Sex: Healthy non-pregnant/non-lactating females.
Females of childbearing potential must have a self-reported negative pregnancy test.
Subject are generally in good health.
Subject with partially grey hair.
Subject with low hair growth and complaint of hair fall.
Subject with self-assessed complaint of thinning of hair.
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.
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.
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.
Subjects are willing to give written informed consent and are willing to follow the study procedure.
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.
Willing to use test product throughout the study period.
|
|
| ExclusionCriteria |
| Details |
History of any dermatological condition of the scalp other than hair loss and/or dandruff.
History of prior use of hair growth treatment within 3 months.
History of any prior hair growth procedures (e.g., hair transplant or laser).
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.
History of alcohol or drug addiction.
Subjects using other marketed hair fall control and/or hair growth products during the study period.
Subjects who have plans of shaving scalp hair during the study.
Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
Subjects having a history or present condition of an allergic response to any cosmetic products.
Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
Pregnant or breastfeeding or planning to become pregnant during the study period.
History of chronic illness which may influence the cutaneous state.
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
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the effectiveness of the test treatments 1, 2, 3, 4 in terms of change in hair density and thickness.
2. To evaluate the effectiveness of test treatments 1,2,3,4 in terms of change in Grey Severity Score (GSS).
3. To evaluate the effectiveness of test treatments 4, 5 in terms of change in hair growth rate.
4. To evaluate the effectiveness of test treatments 4, 5 in terms of change in hair length |
1. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days.
2. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days.
3. 04 days before Day 01, on Day 01 and after usage of test treatments on Day 117 and on Day 120 Days.
4. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of test treatments 1,2,3,4 in terms of change in hair colour- L, a, b and ITA.
|
before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days |
| To evaluate the effectiveness of test treatments 1,2,3,4 in terms of change in hair fall reduction |
before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days |
| To evaluate the effectiveness of test treatments 1,2,3,4 in terms of change in change in appearance of scalp |
before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days |
| To evaluate the effectiveness of test treatments 1,2,3,4 in terms of change in change in hair global colour- number, area, homogeneity, contrast |
before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days |
| To evaluate the effectiveness of test products in terms of subject perception questionnaire |
before usage of test treatments on Day 01, Day 30 Days, Day 60 Days, Day 90 Days and on Day 120 Days |
| To evaluate the effectiveness of test treatments 4, 5 in terms of change in Anagen: Telogen Ratio |
before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days |
| To evaluate the effectiveness of test treatments 4, 5 in terms of change in appearance of scalp |
before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days |
| To evaluate the effectiveness of test treatments 4, 5 in terms of change in hair fall reduction |
before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="4"
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 Proof-of-concept, Single-Blinded, Randomized, Interventional, Prospective, In-Use Safety, Tolerability and Efficacy Study of Anti-Grey Hair and Hair Growth Effect of Test Products. 32 subjects/arm aged 20 to 55 years old healthy human subjects with grey (mild to moderate grey hairs) and hair fall complaints will be enrolled into the study to complete 30 subjects/arm. A total of 160 subjects (32 subjects/arm) will be enrolled in the study to complete 150 subjects (30 subjects/arm). Test Group -A Visit 01 (Day 01): Screening, enrolment, and baseline evaluation Visit 02 (Day 30 Days): Telephonic Follow-Up Visit 03 (Day 60 Days): Telephonic Follow-Up Visit 04 (Day 90 Days): Telephonic Follow-Up Visit 05 (Day 120 Days): Final Evaluation, End of Study Test Group -B Visit 01 (Within 4 Days): Screening Visit 02 (Day 01): Enrolment, Baseline EvaluatioN Visit 03 (Day 30 ± 2 Days): Telephonic Follow-up Visit 04 (Day 60 ± 2 Days): Telephonic Follow-up Visit 05 (Day 90 ± 2 Days): Telephonic Follow-up Visit 06 (Day 117): Tattoo Creation Visit 07 (Day 120): Final Evaluations |