AzTrials
AzTrials

Thinning HairNCT07195487

A Clinical Study to Evaluate the Safety, Effectiveness and In-Use Tolerability of Hair Growth and Scalp Health Serum in Subjects With Mild to Moderate Hair Thinning.

A study testing Fermented Extract Hair Growth and Scalp Health Serum in people with Thinning Hair, run by NovoBliss Research Pvt Ltd at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Thinning Hair
What is being tested?
Fermented Extract Hair Growth and Scalp Health Serum
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteIndia
Study dates
18 Nov 2025to 7 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age: 18-55years (both inclusive) at the time of consent.
  • Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
  • Females of childbearing potential must have a self-reported negative urine pregnancy.
  • Subject is in good general health as determined by the Investigator on the basis of medical history.
  • 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
  • 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.
Show all 12Show fewer
  • 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.
  • Subjects are willing to give written informed consent and are willing to follow the study procedure.
  • 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.
  • Subject is willing and able to comply with study procedures, including all scheduled visits, treatment applications, and assessments.
  • Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
  • Subject must be able to understand and provide written informed consent to participate in the study.

Who cannot join

  • Subject have history of severe hair fall due to any clinically significant self-reported problems like anaemia, thyroid problems.
  • Subject have history of any prior hair growth procedures done (e.g. hair transplant or laser).
  • Subject who had taken topical product of hair loss for at least 4 weeks before enrolment.
  • Subject who had taken any systemic product for any illnesses for at least 3 months.
  • History of alcohol or drug addiction.
  • Subject having history or resent condition of severely irritated or visibly inflamed scalp or severe scalp disease.
Show all 12Show fewer
  • Subject having history or present condition of an allergic response to any cosmetic products, any other condition which could warrant exclusion from the study.
  • Pregnant or breast feeding or planning to become pregnant during the study period.
  • History of chronic illness which may influence the cutaneous state.
  • Subject have participated any clinical research study related to hair care products.
  • 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.
  • Participants with advanced baldness (Norwood 4-7, Ludwig 3), long-standing bald patches (>1 year), scarring alopecia, active scalp infections, recent use of hair growth treatments (e.g., minoxidil or finasteride within the past 3 months), severe scalp conditions, or known allergies to any test product ingredients will be excluded.

Trial locations and contacts

1 site in 1 country.

India1 site
  • NovoBliss Research Private Limited

    Ahmedabad, Gujarat, 380060

Other trials in India

About this study

Official title: 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.

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.

Read the detailed description

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 Visit 01 (Day -04, Week 00): Screening, Informed Consent, Tattoo Marking, Hair Growth Rate Visit 02 (Day 01, Week 00): Randomization, Baseline Evaluations, Buccal DNA Swab Visit 03 (Day 42, Week 06): Tattoo Marking, Hair Growth Rate Visit 04 (Day 45, Week 06): Evaluation Visit 05 (Day 87, Week 12): Tattoo Marking, Hair Growth Rate Visit 06 (Day 90, Week 12): Evaluations, Buccal DNA Swab, End of Study Evaluation parameter: Hair Growth Rate, Thickness, Density, Scalp Condition, A:T Ratio, 60 secs Hair combing, Hair Pull Test, Dermatologist Evaluation, Subjective Response Index, Global Photography of Head Crown, Graying Severity Score (GSS), Tensile Strength

Conditions
Thinning Hair
Being tested
Fermented Extract Hair Growth and Scalp Health Serum, Placebo Hair Growth and Scalp Health Serum
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fermented Extract Hair Growth and Scalp Health SerumOther

    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.

  • Placebo Hair Growth and Scalp Health SerumOther

    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

Study groups in NCT07195487
Study groupRoleWhat they receive
Fermented Extract Hair Growth and Scalp Health SerumExperimentalMode 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.
Receives: Other: Fermented Extract Hair Growth and Scalp Health Serum
Placebo Hair Growth and Scalp Health SerumPlacebo comparatorMode 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
Receives: Other: Placebo Hair Growth and Scalp Health Serum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Hair Growth Rate measured by CASLiteNova from the tattoo-marked area

    Hair growth rate will be assessed using the CASLiteNova from the tattoo-marked area of the scalp. The change from baseline values will be compared within and across treatment arms.

    Measured: Baseline (Day -4 to Day 1, prior to treatment), Day 42 (±2 days), Day 45 (±2 days), Day 87 (±2 days), and Day 90 (±2 days).

  2. Change from Baseline in Baby Hair Count and Hair Length measured by CASLiteNova from the bald scalp area

    Baby hair count and hair length will be evaluated using the CASLiteNova digital imaging system from the bald scalp area. The change from baseline values will be compared within and across treatment arms.

    Measured: Baseline (Day 1, prior to treatment), Day 45 (±2 days), and Day 90 (±2 days).)

  3. Change from Baseline in Hair Density and Hair Thickness measured by CASLiteNova

    Hair density (hairs/cm²) and hair thickness (μm) will be evaluated using the CASLiteNova digital imaging system. The change from baseline values will be compared within and across treatment arms.

    Measured: Baseline (Day 1, prior to treatment), Day 45 (±2 days), and Day 90 (±2 days).

Secondary outcomes (12)
  1. Change from Baseline in Scalp Condition measured by CASLiteNova

    Scalp condition will be evaluated using the CASLiteNova digital imaging system to assess improvements in scalp parameters.

    Measured: Baseline (Day 1, prior to treatment), Day 45 (±2 days), and Day 90 (±2 days).

  2. Change from Baseline in Anagen-to-Telogen (A:T) Hair Ratio measured by CASLiteNova

    The ratio of anagen to telogen hairs will be assessed using the CASLiteNova digital imaging system to evaluate hair growth phase distribution.s

    Measured: Baseline (Day 1, prior to treatment), Day 45 (±2 days), and Day 90 (±2 days).

  3. Change from Baseline in Total Hair Count on the Vertex Region measured by Digital Photography and Image Pro Analysis

    Total hair count on the vertex (crown) region of the scalp will be evaluated using standardized digital photography at a 90° angle and analyzed through image pro analysis software.

    Measured: Baseline (Day 1, prior to treatment), Day 45 (±2 days), and Day 90 (±2 days).

  4. Change from Baseline in General Scalp Appearance evaluated by Dermatologist

    General scalp appearance, including itchiness, redness, roughness, scaliness, and dryness, will be assessed by a dermatologist or a dermatologist-trained evaluator.

    Measured: Baseline (Day 1, prior to treatment), Day 45 (±2 days), and Day 90 (±2 days).

  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

    General hair appearance, including hair volume, plasticity, density, shininess, smoothness, dryness, and strength, will be assessed by a dermatologist or a dermatologist-trained evaluator.

    Measured: Baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 45 (+2 Days) and Day 90 (+2 Days)

  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

    Hair fall, including shedding from the scalp root and hair shaft breakage, will be evaluated using the 60-second hair combing test by a dermatologist-trained evaluator.

    Measured: Baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 45 (+2 Days) and Day 90 (+2 Days)

  7. Improvement in hair root strength evaluated through hair pull test by dermatologist trained evaluator

    Hair root strength will be evaluated using the hair pull test by a dermatologist-trained evaluator.

    Measured: Baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 45 (+2 Days) and Day 90 (+2 Days)

  8. Improvement in tensile strength of single hair strand evaluator through TESTRONIX tensile tester of hair

    Tensile strength of a single hair strand will be measured using a TESTRONIX tensile tester to assess mechanical hair strength.

    Measured: Baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 45 (+2 Days) and Day 90 (+2 Days)

  9. Improvement in extent of hair greying as measured by a Grey Scoring Scale

    The extent of hair greying will be assessed using a validated Grey Scoring Scale to evaluate changes from baseline.

    Measured: Baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 90 (+2 Days)

  10. Change from Baseline in Scalp Microbiome Composition measured by 16S rRNA Gene-Based DNA Sequencing

    Scalp microbiome will be assessed using BD swabs for 16S rRNA gene-based DNA sequencing to evaluate changes in microbial composition from baseline.

    Measured: Baseline (Day 1, prior to treatment) and Day 90 (±2 days).

  11. Change from Baseline in Treatment Perception Questionnaire Score measured by Structured Questionnaire

    Treatment perception will be evaluated using a structured questionnaire. Scores will be compared with baseline values to assess patient-reported outcomes.

    Measured: Baseline (Day 1, prior to treatment), Day 45 (±2 days), and Day 90 (±2 days).

  12. Change from Baseline in Hair Density Patterns measured by Norwood-Hamilton Scale (males) and Ludwig Scale (females)

    Hair density patterns will be assessed using the Norwood-Hamilton scale for male participants and the Ludwig scale for female participants. Changes from baseline will be evaluated.

    Measured: Baseline (Day 1, prior to treatment) and Day 90 (±2 days).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2025
  2. Study start18 Nov 2025
  3. Primary completion7 Apr 2026
  4. Study completion7 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07195487
Sponsor's protocol ID
NB250022-BM_1.0_10Sep25
Status last verified
Nov 2025
First submitted
12 Sep 2025
Last updated
30 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Fermented Extract Hair Growth and Scalp Health Serum in people with Thinning Hair, run by NovoBliss Research Pvt Ltd at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Hair Growth Rate measured by CASLiteNova from the tattoo-marked area (time frame: Baseline (Day -4 to Day 1, prior to treatment), Day 42 (±2 days), Day 45 (±2 days), Day 87 (±2 days), and Day 90 (±2 days).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in