A single blinded (Investigator blinded), randomized study to evaluate and compare the efficacy of the hair leave-on product with a comparator product for scalp hair growth and density
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Significant improvement in scalp hair density as compared to baseline, and comparable improvement in hair density compared to the comparator (benchmark) product in male subjects
研究概览
简要总结
Study Purpose: The study aims at assessing the safety and efficacy of the investigational product for scalp hair growth and hair density as compare to the respective comparator (benchmark) product in male & female subjects
Study Design: A single blinded (Investigator Blinded), randomized, comparative, monocentric, four arms efficacy study.
Study Duration: 183 days (approximately 6 Months) for each subject.
Total No. of visits: 15
Sample size: 200 Subjects
Main Assessment Parameters:
1) Phototrichogram assessment for hair growth, density and A:T ratio.
2) Dermatologist’s assessment of hair and scalp- dermatologist’s assessment for efficacy.
3) Subject’s self assessment, habit questionnaire and comb test.
4) Assessment for product safety by analyzing application site reaction (by dermatologist and subject).
Results: Significant improvement was observed in scalp hair density as compared to baseline and comparable improvement was observed in hair density compared to the comparator product in male and female subjects. The hair density improvement was more in percentage in female subjects. Significant improvement of scalp hair growth as compared to baseline,and comparable improvement in hair growth compared to the comparator product was seen in male and female subjects. Singnificant improvement was observed in scalp and hair condition compared to baseline on application of the test product,and improvement was also compared with the comparator product in male and female subjects.The hair growth and condition was improved and gave good results in male and female subjects.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 21.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects to be 21 to 55 year old male and female generally in good health.
- •Female subjects falling under grade 2, 3 and grade 4 of hair loss severity grade evaluated as per standard Photo numeric 6 point scale.
- •Male subjects falling under grade 2, 3 and grade 4 of hair loss severity grade evaluated as per Norwood scale.
- •Subject having hair density 100-200 /cm2 will be included in the study.
- •Hair falls by comb test to be more than 15 hairs.
- •Subjects who give their consent to the study after thorough explanation and who personally signed and dated the informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
- •Willing to maintain the same hairstyle, hair length and hair color throughout the study.
- •Willingness to have a dot tattoo placed in the target area of the scalp during the study.
- •Willingness to maintain the habits and products during the study.
- •Subjects willing to refrain from other AGA/Female pattern hair loss treatments during the entire study duration.
- •Have no clinically significant disease or abnormal laboratory results taken at the screening visit.
- •Agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, finasteride or dutasteride during the course of this study.
- •Subjects who are not on crash dieting.
排除标准
- •Subjects who are undergoing hair growth treatment 3 months before screening into the study.
- •Subjects who have scalp conditions such as folliculitis, seborrheoic psoriasis of scalp, seborrheoic dermatitis and lichen planopilaris at the time of screening.
- •Subjects who have alopecia areata of scalp hair and scarring alopecia due to any cause such as DLE, SLE and lichen planus.
- •Subjects who have undergone treatments of cancer chemotherapy within 6 months before starting study or plan to undergo the same during study terms.
- •Subjects who have history of alcoholism and/ or psychiatric disorder including trichotillomania.
- •Subjects who have had hair transplantation treatment.
- •Subjects who take pharmaceutical products that may cause hirsutism (ex.
- •phenytoin) and finesteride for androgenic alopecia.
- •A known history or present condition of allergic response/hypersensitivity to any cosmetic ingredients and pharmaceutical products.
- •Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
- •Subjects who are on oral multivitamin tablets containing biotin, zinc, selenium and unwilling to stop the usage 1 month before enrollment into study and throughout the study duration.
- •Subjects with hypertension and thyroid as confirmed by history or blood screening.
- •Female subjects who have been pregnant in last 1 year or lactating or nursing as established by medical history or planning to become pregnant during the study period.
- •Female subjects with the complaint of post pregnancy hair fall.
- •Subjects who have undergone hair dyeing in last 1 month or plan to undergo the same during the study period.
- •Subjects who suffered with acute severe illness in past 3 months as established by the medical history.
- •Chronic illness which may influence the cutaneous state.
- •Subjects participating in other similar cosmetic or therapeutic trial.
- •Any underlying uncontrolled medical illness including diabetes mellitus, HIV, hepatitis, 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 scalp hair density as compared to baseline, and comparable improvement in hair density compared to the comparator (benchmark) product in male subjects
时间窗: 6 Months for each subject
Significant improvement in scalp hair density as compared to baseline, and comparable improvement in hair density compared to the comparator (benchmark) product in female subjects.
时间窗: 6 Months for each subject
次要结局
- Significant improvement in scalp hair growth as compared to baseline, and comparable improvement in hair growth compared to the comparator (benchmark) product in male subjects(Significant improvement in scalp hair growth as compared to baseline, and comparable improvement in hair growth compared to the comparator (benchmark) product in female subjects.)