Study Phase III, Randomized, Double-dummy, Placebo Controlled, Single-center, of Regarding the Non-inferiority of the Medication BL3000, When Compared to Pantogar® Treatment of Telogen Effluvium in Women.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 326
- 主要终点
- Rate difference of anagen hairs at 180 days (FA vf [%]) from baseline rate (FA vi [%]), in participants of each treatment group.
研究概览
简要总结
Study phase III, randomized, double-dummy, placebo controlled, single-center, of regarding the non-inferiority of the medication BL3000, when compared to Pantogar® treatment of telogen effluvium in women.
Research product: BL3000. Reference product: Pantogar® List of Study Center: MAIN INVESTIGATOR STUDY CENTER FONE Medcin Skin Institute Sérgio Schalka 11 36835357
详细描述
Study phase III, randomized, double-dummy, placebo controlled, single-center, of regarding the non-inferiority of the medication BL3000, when compared to Pantogar® treatment of telogen effluvium in women. 326 female patients will be recruited for the study. They will be aged from 18 to 45 years old, not menopausal, diagnosed with telogen effluvium proven by Trichoscan, who meet the inclusion criteria and do not meet the exclusion criteria and who sign the Informed Consent Form.
Patients will be divided into two treatment groups according to randomization:
Group I: 163 patients will receive treatment with the medication BL3000 and matching placebo of pantogar.
Group II: 163 patients will receive treatment with the reference drug (Pantogar®) and matching placebo of BL3000.
The patients will participate in the study for a period of 199 (one hundred and ninety-nine) days, using of the investigational or comparative product for 180 (one hundred and eighty) days,
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-dummy
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged from 18 to 45 years old;
- •Clinical/trichological evidence of telogen effluvium, assessed using the Telogen Index.
- •Participants will be eligible if they have a rate strand of hair ≥ 20% of the total quantified by Thrichoscan measurement in the central-parietal region;
- •Complaint of hair loss for at least 3 months prior to screening;
- •Agreement to obey the procedures and requirements of the protocol and to attend the Research Institution on the day (s) and time (s) determined for the evaluations;
- •Signature of the Informed Consent Form; SAW. Agreement to use an acceptable non-hormonal contraceptive method throughout the period of treatment and up to 60 days after the end of the study;
- •Serum creatinine within the normal range;
- •Relationship between AST / ALT transaminases ≤ 2.5x the upper limit of normal
排除标准
- •Pregnancy or pregnancy risk;
- •Childbirth occurred in the last 12 months;
- •Patient who has undergone surgical procedures or has suffered trauma in the last 6 months;
- •History of bleeding events in the last 6 months, SAW. Clinical evidence of female androgenic alopecia or alopecia areata;
- •Patients with signs of menopause: menstrual irregularities or cycle failure, signs of climacteric;
- •Laboratory evidence of thyroid diseases (variation in TSH and / or free T4 values outside normal limits);
- •Clinical evidence of ovarian or adrenal endocrine disorders (polycystic ovaries, hirsutism, menstrual irregularities);
- •History or presence of systemic autoimmune disease;
- •Start or end of hormone therapy within 6 months before randomization;
- •Deficiency diseases;
- •Introduction, change or interruption of a hormonal contraceptive method in the last 6 months before randomization;
- •Introduction of a restrictive diet in the last 03 months before randomization;
- •Use of any continuous medication;
- •Diabetes, chronic consuming disease, malabsorptive syndrome or diseases of the gastrointestinal tract;
- •Infectious or chronic fever;
- •Psychiatric/psychological illnesses, such as depression, anxiety or obsessive disorders;
- •Clinical and / or laboratory evidence of anemia or ferropenia; (Hb <12 g / dL and Ferritin <40 g / L);
- •Hair treatment to control hair loss (including shampoo, conditioner, lotions);
- •Hair growth agent treatment within 3 months before randomization;
- •Concomitant use of drugs that cause hair loss;
- •Patient with a history of allergic reaction or hypersensitivity to any formulation ingredients;
- •Other conditions considered by the evaluating physician to be reasonable for disqualifying the participation in the study.
研究组 & 干预措施
BL 3000 (active) and Pantogar matching Placebo
One capsule, once a day for 180 days for BL3000 and one capsule three times a day for Pantogar-Placebo.
干预措施: BL 3000 (Drug)
BL 3000 (active) and Pantogar matching Placebo
One capsule, once a day for 180 days for BL3000 and one capsule three times a day for Pantogar-Placebo.
干预措施: Pantogar - Placebo (Drug)
Pantogar and BL3000 matching placebo
One capsule, three times a day for 180 days
干预措施: Reference Pantogar (Drug)
Pantogar and BL3000 matching placebo
One capsule, three times a day for 180 days
干预措施: BL3000 Placebo (Drug)
结局指标
主要结局
Rate difference of anagen hairs at 180 days (FA vf [%]) from baseline rate (FA vi [%]), in participants of each treatment group.
时间窗: 180 days
Assess the non-inferiority of the effectiveness of the BL3000 drug compared to the drug. The counting of anagen and telogen performed by phototrichogram in the initial and final experimental times, with the calculation proposed according to the protocol below: The primary variable of efficacy will be the rate of anagen hairs (FA) (%), 45.90 and 180 days in relation to the beginning, between the two arms of treatment (test versus control). Calculated as follows: FA (vi): result of anagen (%) on visit 04 (T0); FA (vf): result of anagen (%) on visit 10 (T182). Response rate of anagen (%), FA = (FA (vf)-FA (vi)).
次要结局
- Difference of the total count of strand hair per mm² (density) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.(45,90 and 180 days)
- Difference of the number of anagen hairs per mm² (density) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.(45,90 and 180 days)
- Difference of the number of telogen hairs per mm² (density) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.(45,90 and 180 days)
- Difference of the anagen/telogen hair ratio at the experimental times frames, compared to the baseline evaluation, in participants of each treatment group.(45,90 and 180 days)
- Difference of the strand hair thickness (mm²) at the experimental time frames, compared to the baseline evaluation, in participants of each treatment group.(45,90 and 180 days)
- Proportion of "Excellent" and "Very good" change of the telogen effluvium, as assessed by the investigator, comparing photographs taken at final visit and baseline visit, in participants of each treatment group.(180 days)
- Proportion of "Much better" and "best" change, based on the participant's subjective assessment, from each treatment group, using a Likert scale.(45,90 and 180 days)
- Number of participants with treatment-related adverse events in each treatment group(180 days)