NCT07195487

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 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.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	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.
OTHER	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

Timeline

• Start date: 2025-11-18
• Primary completion: 2026-04-06
• Completion: 2026-04-06
• First posted: 2025-09-26
• Last updated: 2026-01-30

Locations

1 site across 1 country: India