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.

NCT07195487 | Active Not Recruiting

• 1 other identifier: NB250022-BM_1.0_10Sep25
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Thinning Hair

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

• 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.

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

• 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.

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

Secondary Outcomes (12)

• Change from Baseline in Scalp Condition measured by CASLiteNova

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

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

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

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

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

• Change from Baseline in General Scalp Appearance evaluated by Dermatologist

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

• 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

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

Study Arms (2)

Fermented Extract Hair Growth and Scalp Health Serum

EXPERIMENTAL

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.

Other: Fermented Extract Hair Growth and Scalp Health Serum

Placebo Hair Growth and Scalp Health Serum

PLACEBO COMPARATOR

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

Other: Placebo Hair Growth and Scalp Health Serum

Interventions

Placebo Hair Growth and Scalp Health Serum OTHER

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 Serum

Fermented Extract Hair Growth and Scalp Health Serum OTHER

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.

Fermented Extract Hair Growth and Scalp Health Serum

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• NovoBliss Research Pvt Ltd: lead
• Blossom Microbiotics LLC: collaborator

Study Sites (1)

NovoBliss Research Private Limited

Ahmedabad, Gujarat, 380060, India

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Nayan Patel

  NovoBliss Research Pvt Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 26, 2025
• Study Start: November 18, 2025
• Primary Completion: April 6, 2026
• Study Completion: April 6, 2026
• Last Updated: January 30, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)