Proof-of-concept, Single-Blinded, Randomized, Interventional, Prospective, In-Use Safety, Tolerability and Efficacy Study of Anti-Grey Hair and Hair Growth Effect of Test Products.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- 1. To evaluate the effectiveness of the test treatments 1, 2, 3, 4 in terms of change in hair density and thickness.
研究概览
简要总结
This is Proof-of-concept, Single-Blinded, Randomized, Interventional, Prospective, In-Use Safety, Tolerability and Efficacy Study of Anti-Grey Hair and Hair Growth Effect of Test Products.
32 subjects/arm aged 20 to 55 years old healthy human subjects with grey (mild to moderate grey hairs) and hair fall complaints will be enrolled into the study to complete 30 subjects/arm.
A total of 160 subjects (32 subjects/arm) will be enrolled in the study to complete 150 subjects (30 subjects/arm).
Test Group -AVisit 01 (Day 01): Screening, enrolment, and baseline evaluation
Visit 02 (Day 30 Days): Telephonic Follow-Up
Visit 03 (Day 60 Days): Telephonic Follow-Up
Visit 04 (Day 90 Days): Telephonic Follow-Up
Visit 05 (Day 120 Days): Final Evaluation, End of Study
Test Group -B
Visit 01 (Within 4 Days): Screening
Visit 02 (Day 01): Enrolment, Baseline EvaluatioN
Visit 03 (Day 30 ± 2 Days): Telephonic Follow-up
Visit 04 (Day 60 ± 2 Days):Telephonic Follow-up
Visit 05 (Day 90 ± 2 Days): Telephonic Follow-up
Visit 06 (Day 117): Tattoo Creation
Visit 07 (Day 120): Final Evaluations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
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 grey 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
- •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.
- •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 evaluate the effectiveness of the test treatments 1, 2, 3, 4 in terms of change in hair density and thickness.
时间窗: 1. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days. | 2. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days. | 3. 04 days before Day 01, on Day 01 and after usage of test treatments on Day 117 and on Day 120 Days. | 4. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days.
2. To evaluate the effectiveness of test treatments 1,2,3,4 in terms of change in Grey Severity Score (GSS).
时间窗: 1. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days. | 2. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days. | 3. 04 days before Day 01, on Day 01 and after usage of test treatments on Day 117 and on Day 120 Days. | 4. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days.
3. To evaluate the effectiveness of test treatments 4, 5 in terms of change in hair growth rate.
时间窗: 1. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days. | 2. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days. | 3. 04 days before Day 01, on Day 01 and after usage of test treatments on Day 117 and on Day 120 Days. | 4. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days.
4. To evaluate the effectiveness of test treatments 4, 5 in terms of change in hair length
时间窗: 1. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days. | 2. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days. | 3. 04 days before Day 01, on Day 01 and after usage of test treatments on Day 117 and on Day 120 Days. | 4. before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days.
次要结局
- To evaluate the effectiveness of test treatments 1,2,3,4 in terms of change in hair colour- L, a, b and ITA.
- To evaluate the effectiveness of test treatments 1,2,3,4 in terms of change in hair fall reduction(before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days)
- To evaluate the effectiveness of test treatments 1,2,3,4 in terms of change in change in appearance of scalp(before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days)
- To evaluate the effectiveness of test treatments 1,2,3,4 in terms of change in change in hair global colour- number, area, homogeneity, contrast(before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days)
- To evaluate the effectiveness of test products in terms of subject perception questionnaire(before usage of test treatments on Day 01, Day 30 Days, Day 60 Days, Day 90 Days and on Day 120 Days)
- To evaluate the effectiveness of test treatments 4, 5 in terms of change in Anagen: Telogen Ratio(before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days)
- To evaluate the effectiveness of test treatments 4, 5 in terms of change in appearance of scalp(before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days)
- To evaluate the effectiveness of test treatments 4, 5 in terms of change in hair fall reduction(before usage of test treatments on Day 01 and after usage of test treatments on Day 120 Days)
研究者
Dr Nayan Patel
NovoBliss Research Private Limited