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| Name | Class |
|---|---|
| Blossom Microbiotics LLC | OTHER |
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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 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nayan Patel | NovoBliss Research Pvt Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NovoBliss Research Private Limited | Ahmedabad | Gujarat | 380060 | India |
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| 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 |
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The ratio of anagen to telogen hairs will be assessed using the CASLiteNova digital imaging system to evaluate hair growth phase distribution.s |
| 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 | 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. | 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 | General scalp appearance, including itchiness, redness, roughness, scaliness, and dryness, will be assessed by a dermatologist or a dermatologist-trained evaluator. | 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 | General hair appearance, including hair volume, plasticity, density, shininess, smoothness, dryness, and strength, will be assessed by a dermatologist or a dermatologist-trained evaluator. | Baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 45 (+2 Days) and Day 90 (+2 Days) |
| 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. | Baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 45 (+2 Days) and Day 90 (+2 Days) |
| 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. | Baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 45 (+2 Days) and Day 90 (+2 Days) |
| 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. | Baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 45 (+2 Days) and Day 90 (+2 Days) |
| 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. | Baseline (Day 01, prior to treatment usage) to post treatment assessments on Day 90 (+2 Days) |
| 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. | Baseline (Day 1, prior to treatment) and Day 90 (±2 days). |
| 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. | Baseline (Day 1, prior to treatment), Day 45 (±2 days), and Day 90 (±2 days). |
| 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. | Baseline (Day 1, prior to treatment) and Day 90 (±2 days). |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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