Controlled, Randomized, Double Blind Study, for the Evaluation of Tolerance and Trichological Efficacy of a Food Supplement: Bioscalin® New Formulation Versus Reference Formulation Currently on the Market and Placebo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Derming SRL
- 入组人数
- 51
- 主要终点
- Change from baseline of the percentage of hair in anagen phase
研究概览
简要总结
Controlled, randomized, double blind study, for the evaluation of tolerance and trichological efficacy of a food supplement: Bioscalin® new formulation versus reference formulation currently on the market and placebo
详细描述
Aim of the study was to evaluate clinically and by non-invasive instrumental measurements the trichological activity of a food supplement taken for 3 months by subjects of both sexes, aged between 18-60 years, affected by telogen effluvium, with a percentage of hair in anagen phase < 75%.
In particular the study foresaw the evaluation of the trichological activity of the Bioscalin® new formulation with Galeopsis Segetum in comparison to a reference product currently on the market and to placebo.
It was also aim of this study to evaluate treatment tolerance.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •both sexes;
- •age range 18-60 years old;
- •with telogen effluvium and a percentage of anagen ratio at inclusion < 75%;
- •no-smokers;
- •accepting to follow the instruction received by the investigator;
- •disposable and able to return to the study centre at the established times;
- •accepting to not change their habits regarding food, physical activity, hair and scalp cleansing;
- •accepting to not receive any drugs/cosmetics treatment able to interfere with the study results;
- •no participation in a similar study actually or during the previous 6 months;
- •accepting to sign the Informed consent form.
排除标准
- •Pregnancy (for female subjects);
- •lactation (for female subjects);
- •subjects not in menopause who does not use adequate contraceptive precautions in order to avoid pregnancies during the study;
- •subjects not in menopause who do not accept to perform the pregnancy test during the basal visit, after 2 (T2) and 3 (T3) month-treatment;
- •change in the normal habits regarding food, physical activity, physical activity, hair and scalp cleansing during the month preceding the test;
- •sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit). The product contains gluten (aroma of grain), then all subjects with celiac disease or gluten intolerance should be excluded.
- •subjects whose insufficient adhesion to the study protocol is foreseeable;
- •participation in a similar study actually or during the previous 6 months.
- •presence of cutaneous disease on the tested area, as lesions, scars, malformations;
- •clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.).
- •endocrine disease
- •hepatic disorder
- •renal disorder
- •cardiac disorder
- •pulmonary disease
- •neurological or psychological disease
- •inflammatory/immunosuppressive disease
- •drug allergy
- •anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);
- •assumption of drugs able to influence the test results in the investigator opinion.
研究组 & 干预措施
Bioscalin® new formulation with Galeopsis Segetum
2 placebo capsules + 1 Bioscalin with Galeopsis Segetum table
干预措施: Bioscalin® new formulation with Galeopsis Segetum (Dietary Supplement)
REFERENCE PRODUCT
2 reference product capsules + 1 placebo tablet
干预措施: Reference product (Dietary Supplement)
PLACEBO
2 placebo capsules + 1 placebo tablet
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change from baseline of the percentage of hair in anagen phase
时间窗: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
Percentage of hair in anagen phase (anagen hair grow \> 0,3 mm/die ) was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.
Change from baseline of the hair density
时间窗: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
Hair density (hair number/cm2) was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.
Change from baseline of the percentage of vellus hair
时间窗: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
Percentage of vellus hair (vellus hair has a diameter \<0.04 mm)was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.
次要结局
- Videodermatoscopy(Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).)
- Pull test(Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).)
- Sebometry(Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).)
- Hair parting test(Basal visit (T0), after 1 (T1), 2 (T2) and 3 (T3) month-treatment and a follow-up visit 1 month after the last food supplement assumption (T4 months).)
研究者
Adele Sparavigna
Dermatologist, Principal Investigator
Derming SRL