Clinical evaluation of the safety and efficacy of the investigational product containing herbal actives for hair growth and hair quality in subjects experiencing hair loss
试验速览
- 阶段
- 1/2 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Significant improvement in hair fall reduction, improvement in hair growth, improvement in hair density, hair thinning, thickness and hair strength in comparison to baseline and observational group
研究概览
简要总结
Pri****mary objectives:
· To assess theefficacy of testproducts in hair fallreduction and improving hair growth
· To assess theefficacy of testproducts in improving hairdensity and thickness
· To assess theefficacy of testproduct in providing hairstrength
· Toevaluate the impact of the test product on hair thinning
Secondary objectives:
· Toevaluate the safety of the test products with respect to local intolerances andadverse events (product related) reported during the study
· To evaluate overall improvement in hair quality such as anchoragestrand breaks/from root, dryness, texture, detangling, shine, reduction ingraying etc.
· Improvementin scalp condition and perceived benefits as per subject’s sensorial assessment.
· Subjectself assessment for hair growth, density and quality
. To evaluate the product acceptance as per subject’s sensorial assessment.
Study Duration:
Approximately 108 days (15 weeks) for eachsubject.
Sample Size:
Total of 90subjects divided equally into three groups.
Study Design:
Single blinded (Investigator blinded),randomized, comparative, monocentric, three arms efficacy study.pan>ts divided equally into three groups.
Study Visits:
Total 10 Visits.
Main Assessment Parameters:
Primary Assessments:
Efficacy assessment by Dermatologist:
- Dermatologist’s assessment for efficacy
- Phototrichogram imaging for density, hair length (hair growth), A: T ratio and Ratio of Vellus and Terminal hair
- Hair fall by comb test- Test for hair fall from root, hair breakage
- Hair Thinning measurement as per the photonumeric linear scale (10 point scale)
- Hair fall by pull test- test for anchorage
- Image transition matrix- Improvement in hair thinning
Instrumental Measurements:
- Follicular Density by Phototrichogram
- Assessment of hair growth rate by Phototrichogram
- A:T ratio by Phototrichogram
- Hair thickness using Casalite nova.
- Tensile strength
Secondary Assessments:
1. Safety Assessment by dermatologists
· Local Intolerance
· Dermat assessment for site applicationreaction
· Subject assessment for site applicationreaction
2. Norwood scale for male subjects (7 pointscale) and Ludwig scale for female subjects will be used for assessments atbaseline and end of the study to establish a correlation between MSCR andStandard (Norwood and Ludwig) scale.
3. Subject self assessment for safety along with perceived benefits
Hair sampling on baseline and end of the study will be performed andshipped to the sponsor for further analysis
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects’ in general good health.
- •2.Subjects in the age group 18-45 years (both the ages inclusive).
- •3.Subjects willing to give a written informed consent and agree to come for a regular follow up visit.
- •4.Subjects with hair fall- above 20 hair fall in comb test (with bulb+ without bulb) 5.Subjects with follicular density above 100-200 6.Subjects complaining of hair fall 7.Subjects complaining about hair thinning 8.Subjects who have not participated in a similar investigation in the past three months.
- •9.Healthy volunteers with no known allergy as established by medical history.
- •10.Subjects who do not smoke or drink 11.Subjects who are not crash dieting.
- •12.Subjects who agree to refrain from using hair dye / hair color during the study period.
- •13.Subjects willing to refrain from any type of hair treatment like perming, straightening etc.
- •during the study duration.
- •14.Subjects with regular oiling habits.
排除标准
- •1.A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
- •2.Subjects who have had hair transplant.
- •3.Subjects who take pharmaceutical product which cause hirsutism (ex.
- •phenytoin) and finesteride for androgenic alopecia 4.Subjects who have undergone hair growth treatment within 3 months before screening into the study.
- •5.Subjects having any active scalp diseasewhichmayinterfere in the studydermatologist’sjudgement.
- •6.Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study.
- •8.Subjects consuming alcohol and smoking 9.Subjects on oral medications which will compromise the study.
- •10.Subjects who are pregnant or lactating or nursing as established with medical history.
- •11.Under medical treatment for hair problems 12.Undergoing any chemical hair salon treatment- straightening / perming / colour 13.Menopausal female subjects as determined by medical history.
- •14.Pregnant female subjects as determined by UPT test 15.Chronic illness which may influence the cutaneous state.
- •Subjects participating in other similar cosmetic or therapeutic trial within last three months 16.Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness.
结局指标
主要结局
Significant improvement in hair fall reduction, improvement in hair growth, improvement in hair density, hair thinning, thickness and hair strength in comparison to baseline and observational group
时间窗: Approximately 108 days for each subject
Equivalence or superiority of efficacy in hair fall reduction improving hair growth, improvement in hair density, thickness and hair strength in comparison to comparator group.
时间窗: Approximately 108 days for each subject
次要结局
- Significant product tolerance in terms of local intolerance and product related AE reported during the study(Approximately 108 days for each subject)