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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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, Evaluation of hair growth
- 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): Evaluations
- Visit 05 (Day 87, Week 12): Tattoo Marking, Hair Growth Rate
- Visit 06 (Day 90, Week 12): Evaluations, BD Swab collection and End of Study
- Evaluations : 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 (Image Pro Analysis), Greying Severity Score (GSS), Tensile strength
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •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 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.
- •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 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.
排除标准
- •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 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.
- •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 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.
结局指标
主要结局
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.
时间窗: 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)
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.
时间窗: 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)
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.
时间窗: 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)
次要结局
- 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)
研究者
Dr Apeksha Merja MD Dermatologist
NovoBliss Research Pvt. Ltd.