A Study to Evaluate the Safety and Effectiveness of a Hair Growth Serum in Adults with Mild to Moderate Hair Thinning.
Scientific Title of Study
A Randomized, Double Blind, Placebo-Controlled, Single-Center Clinical Study to Assess the Safety, Efficacy, and In-Use Tolerability of a Fermented Hair Growth and Scalp Health Serum in Subjects with Mild to Moderate Hair Thinning.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NB250022-BM_1.0_10Sep25
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Apeksha Merja MD Dermatologist
Designation
Principal Investigator
Affiliation
NovoBliss Research Pvt. Ltd.
Address
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India
Ahmadabad GUJARAT 382481 India
Phone
07948983895
Fax
Email
dermatology@novobliss.in
Details of Contact Person Scientific Query
Name
Dr Nayan Patel MBBS
Designation
Sub Investigator
Affiliation
NovoBliss Research Pvt. Ltd.
Address
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India
Ahmadabad GUJARAT 382481 India
Phone
07948983895
Fax
Email
dr.nayan@novobliss.in
Details of Contact Person Public Query
Name
Maheshvari Patel
Designation
Director Operations and Strategic Management
Affiliation
NovoBliss Research Pvt. Ltd.
Address
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India
Ahmadabad GUJARAT 382481 India
Phone
07948983895
Fax
Email
maheshvari@novobliss.in
Source of Monetary or Material Support
Blossom Microbiotics LLC
4111-E Rose Lake Dr #6005,
Charlotte, North Carolina
Primary Sponsor
Name
Blossom Microbiotics LLC
Address
4111-E Rose Lake Dr #6005,
Charlotte, North Carolina
Type of Sponsor
Other [Biotechnology company specializing in microbial solution]
Details of Secondary Sponsor
Name
Address
Nil
N/A
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 MBBS
NovoBliss Research Private Limited
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India -
Ahmedabad, Gujarat, India - 382481. Ahmadabad GUJARAT
15-20 % Fermented Extract Hair Growth and Scalp Health Serum
Mode of Usage: Apply the serum directly to the scalp using the rollerball applicator. Gently roll the ball over thinning or affected areas of the scalp. Gently massage the serum into the scalp with clean fingertips to help it absorb fully. Ensure liquid is visible on the scalp and reapply until you feel a cooling wet sensation during application — this confirms the mechanism is working and that a good amount of product is being delivered.
Frequency: Apply the treatment twice daily- once after morning shower and once before bed time. immediately after shower and at night before bed.
Route of administration: Topical
Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight.
Comparator Agent
Placebo Hair Growth and Scalp Health Serum
Mode of Usage: Apply the serum directly to the scalp using the rollerball applicator. Gently roll the ball over thinning or affected areas of the scalp. Gently massage the serum into the scalp with clean fingertips to help it absorb fully. Ensure liquid is visible on the scalp and reapply until you feel a cooling wet sensation during application — this confirms the mechanism is working and that a good amount of product is being delivered.
Frequency: Apply the treatment twice daily - once after morning shower and once before bed time. immediately after shower and at night before bed.
Route of administration: Topical
Storage Condition: Store at room temperature 15°C to 30°C, away from sunlight
Inclusion Criteria
Age From
18.00 Year(s)
Age To
55.00 Year(s)
Gender
Both
Details
1) Age 18-55years (both inclusive) at the time of consent.
2) Sex Males and non-pregnant non-lactating females (preferably equal number of males and females).
3) Females of childbearing potential must have a self-reported negative urine pregnancy.
4) Subject is in good general health as determined by the Investigator on the basis of medical history.
5) Patients must have a confirmed diagnosis of mild to moderate hair thinning, during clinical study and grade will be evaluated by the dermatologist by using Norwood-Hamilton classification for male (Grade 1–3) and Ludwig pattern scale for female (Grade 1–2) with active hair shredding
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 any other medicated, prescription shampoos, hair care products, any other hair growth products or hair colour or dye, other than the test treatment for the entire duration of the study.
10) Subject is willing and able to comply with study procedures, including all scheduled visits, treatment applications, and assessments.
11) Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
12) Subject must be able to understand and provide written informed consent to participate in the study.
ExclusionCriteria
Details
1) Subject have history of severe hair fall due to any clinically significant self-reported problems like anaemia, thyroid problems.
2) Subject have history of any prior hair growth procedures done hair transplant or laser.
3) Subject who had taken topical product of hair loss for at least 4 weeks before enrolment.
4) Subject who had taken any systemic product for any illnesses for at least 3 months.
5) History of alcohol or drug addiction.
6) Subject having history or resent condition of severely irritated or visibly inflamed scalp or severe scalp disease.
7) Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
8) Pregnant or breast feeding or planning to become pregnant during the study period.
9) History of chronic illness which may influence the cutaneous state.
10) Subject have participated any clinical research study related to hair care products.
11) Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or product of any type of cancer within the last 6 months.
12) Participants with advanced baldness Norwood 4–7, Ludwig 3, long-standing bald patches more than 1 year, scarring alopecia, active scalp infections, recent use of hair growth treatments minoxidil or finasteride within the past 3 months, severe scalp conditions, or known allergies to any test product ingredients will be excluded.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
1. Improvement in Hair Growth Rate evaluated through CASLiteNova from the tattoo markerd area from baseline on- 4 days prior to Day 01, on Day 01(prior to treatment usage)to post treatment assessments on Day 42(+2 Days), Day 45(+2 Days), Day 87 (+2 Days) and Day 90(+2 Days), assessed within each treatment arms and across treatment arms.
2. Improvement in Hair Growth in term of hair length evaluated through CASLiteNova, from baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 45 (+2 Days) and Day 90 (+2 Days), assessed within each treatment arms and across treatment arms.
3. Improvement in Hair Density and Hair thickness evaluated through CASLiteNova, from baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 45 (+2 Days) and Day 90 (+2 Days), assessed within each treatment arms and across treatment arms.
1. On- 4 days prior to Day 01, on Day 01, Day 42(+2 Days), Day 45(+2 Days), Day 87 (+2 Days) and Day 90(+2 Days).
2. Day 01, Day 45(+2 Days), Day 90(+2 Days)
3. Day 01, Day 45 (+2 Days) and Day 90 (+2 Days)
Secondary Outcome
Outcome
TimePoints
1. Improvement in Scalp Condition evaluated through CASLiteNova, from baseline to post treatment assessments assessed within each treatment arms and across treatment arms.
Baseline on Day 01, Day 45, Day 90
2. Improvement in A:T Ratio evaluated through CASLiteNova, from baseline prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.
Baseline on Day 01, Day 45, Day 90
3. Improvement in total hair count on the vertex (head crown) region of the scalp evaluated through digital photography capture at 90° angle and analyzed through image pro analysis, from baseline- prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.
Baseline on Day 01, Day 45, Day 90
4. Improvement in general appearance of scalp i.e. itchiness, redness, roughness, scaliness and dryness evaluated by the Dermatologist or Dermatologist trained evaluator, from baseline- prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.
Baseline on Day 01, Day 45, Day 90
5. Improvement in general appearance of hair i.e. hair volume, hair plasticity, hair density, hair shininess, hair smoothness, hair dryness and hair strength evaluated by the Dermatologist or Dermatologist trained evaluator, from baseline- prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.
Baseline on Day 01, Day 45, Day 90
6. Improvement in hair fall- both from the scalp root and due to hair shaft breakage evaluated through 60 second hair combing test by dermatologist trained evaluator, from baseline- prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.
Baseline on Day 01, Day 45, Day 90
7. Improvement in hair root strength evaluated through hair pull test by dermatologist trained evaluator, from baseline- prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.
Baseline on Day 01, Day 45, Day 90
8. Improvement in tensile strength of single hair strand evaluator through TESTRONIX tensile tester of hair, from baseline- prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.
Baseline on Day 01, Day 45, Day 90
9. Improvement in extent of hair greying as measured by a Grey Scoring Scale from baseline- prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.
Baseline on Day 01, Day 45, Day 90
10. Improvement in scalp microbiome as measured by BD swab for 16s rRNA gene-based DNA sequencing from baseline- prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms
Baseline on Day 01 and Day 90
11. 2. Improvement in treatment perception questionnaire score as measured by a structured questionnaire from baseline- prior to treatment usage to post treatment assessments, assessed within each treatment arms and across treatment arms.
Baseline on Day 01, Day 45, Day 90
12. Improvement in hair density patterns as measured by Norwood-Hamilton scale in male and Ludwig scale in female from baseline- prior to treatment usage to post treatment assessment, assessed within each treatment arms and across treatment arms.
Baseline on Day 01 and Day 90
Target Sample Size
Total Sample Size="34" Sample Size from India="34" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
01/10/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
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 a Prospective, Interventional,
Randomized, Double-Blind, Placebo-Controlled, Single-Centre, Clinical Study to
Evaluate the Safety, Efficacy and In-Use Tolerability of Fermented Extract Hair
Growth and Scalp Health Serum. A total of 34 participants, including males and
non- pregnant, non-lactating females aged between 18 and 55years (inclusive)
with Mild to Moderate Hair Thinning will be enrolled in the study. The study
aims to complete evaluation for 30 participants, from that 20 subjects in the
Treatment A group (bioactive) and 10 subjects in the Treatment B group
(placebo). Scalp skin type- categorized as dry, oily, or combination-will be
recorded during screening.
There will be total of 6 visits during the
study. The duration of the study will be 90 Days (3 months) from the enrolment.