An Open-Label, Non-Randomized, Single-Arm, Single-Centre, Prospective, Interventional, Safety, Efficacy and Tolerability Study of Hair Growth and Anti-Gray Hair Serum in Healthy Adult Females with Partially Gray Hairs and Hair Fall Complaints.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- 1.To assess the hair growth on the scalp using CASLite Nova.
研究概览
简要总结
An Open-Label, Non-Randomized, Single-Arm, Prospective, Interventional, Safety, Tolerability and Efficacy Study of Hair Growth and Anti-Gray Hair Serum in Healthy Adult Females with Partially Gray Hairs and Hair Fall Complaints.
A total up to 32 healthy adult non-pregnant/non-lactating females with the age of 20-55 years, with partially grey hairs and hair fall complaints will be enrolled to ensure a total of 30 subjects complete the study.
Subjects will be instructed to visit the facility as per the below visit.
Visit 01 (Day -04) Screening
Visit 02 (Day 01) Enrolment and Baseline Readings
Visit 03 (Day 45) Test Product Usage Phase, Evaluations
Visit 04 (Day 87) Test Product Usage Phase, Tattoo and Hair Growth Measurement
Visit 05 (Day 90) Test Product Usage Phase, Evaluation
Visit 06 (Day 120) End of Visit, Test Product Usage Phase, Evaluations
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age: 20 to 55 years (both inclusive) at the time of consent.
- •Sex: Healthy non-pregnant/non-lactating females.
- •Females of childbearing potential must have a self-reported negative pregnancy test.
- •Subject are generally in good health.
- •Subject with partially gray hair.
- •Subject with low hair growth and complaint of hair fall.
- •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.
- •If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
- •Subjects are willing to give written informed consent and are willing to follow the study procedure.
- •Subjects who commit not to use medicated/ prescription shampoos/hair care products (containing Minoxidil), any other hair growth hair products or hair colour or dye, other than the test products for the entire duration of the study.
排除标准
- •Subjects with any other hair colour except gray.
- •History of any dermatological condition of the scalp other than hair loss and/or dandruff.
- •History of prior use of hair growth treatment within 3 months.
- •History of any prior hair growth procedures (e.g., hair transplant or laser).
- •Subjects who have applied topical treatment for hair loss for at least 4 weeks and any systemic treatment for at least 3 months, before they participated in the study.
- •History of alcohol or drug addiction.
- •Subjects using other marketed hair fall control and/or hair growth products during the study period.
- •Subjects who have plans of shaving scalp hair during the study 9)Subjects who are on chronic oral steroids 03 months before initial application and during the study period.
- •History or present condition of irritated or visibly inflamed scalp or severe scalp disease.
- •Subjects having a history or present condition of an allergic response to any cosmetic products.
- •Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
- •Pregnant or breastfeeding or planning to become pregnant during the study period.
- •History of chronic illness which may influence the cutaneous state.
- •Subjects participating in other similar cosmetics, devices or therapeutic trials or hair/scalp care products within the last four weeks.
结局指标
主要结局
1.To assess the hair growth on the scalp using CASLite Nova.
时间窗: 1.For hair growth on the scalp from (Day -04) before test product usage and after product usage on Day 01, Day 87, Day 90. | 2.For other parameters from baseline before usage Day 01 and on Day 45 ,Day 90 and Day 120 post product usage.
2.To assess the effectiveness of the test product in terms of change in A:T ratio using Phototrichogram.
时间窗: 1.For hair growth on the scalp from (Day -04) before test product usage and after product usage on Day 01, Day 87, Day 90. | 2.For other parameters from baseline before usage Day 01 and on Day 45 ,Day 90 and Day 120 post product usage.
3. To assess the effectiveness of the test product in terms of change in hair density and hair thickness using CASLite Nova.
时间窗: 1.For hair growth on the scalp from (Day -04) before test product usage and after product usage on Day 01, Day 87, Day 90. | 2.For other parameters from baseline before usage Day 01 and on Day 45 ,Day 90 and Day 120 post product usage.
4. To assess the effectiveness of the test product in terms of change in hair fall using 60 sec hair comb test.
时间窗: 1.For hair growth on the scalp from (Day -04) before test product usage and after product usage on Day 01, Day 87, Day 90. | 2.For other parameters from baseline before usage Day 01 and on Day 45 ,Day 90 and Day 120 post product usage.
5. To assess the effectiveness of the test product in terms of change in graying severity score by dermetologidt trained scorer and dermatologist.
时间窗: 1.For hair growth on the scalp from (Day -04) before test product usage and after product usage on Day 01, Day 87, Day 90. | 2.For other parameters from baseline before usage Day 01 and on Day 45 ,Day 90 and Day 120 post product usage.
次要结局
- 1. To assess the effect of the test product in terms of scalp skin appearance i.e. itchiness, redness, roughness and scaliness of scalp evaluated by dermatologist trained evaluator or dermatologist.(From baseline on day 01 before test product usage and on day 45, day 90 and day 120 post product usage.)
- 2.To assess the consumer perception about product using subjective questionnaire(Before usage Day 01 and on day 45 ,day 90 and day 120 post product usage.)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited