Evaluation of Tolerance and Trichological Efficacy of a Food Supplement

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Telogen Effluvium

Intervention / Treatment
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* Dietary Supplement: Bioscalin® new formulation with Galeopsis Segetum
* Dietary Supplement: Reference product
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.). Diabetes endocrine disease hepatic disorder renal disorder cardiac disorder pulmonary disease cancer 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bioscalin® new formulation with Galeopsis Segetum<br>2 placebo capsules + 1 Bioscalin with Galeopsis Segetum table | Dietary Supplement: Bioscalin® new formulation with Galeopsis Segetum<br>* Total duration of the study was 4 months; each subject, took by mouth two capsules/die of placebo at breakfast and one tablet/die of study product at lunch for the first 3 months of the trial.<br>|
| Active Comparator: REFERENCE PRODUCT<br>2 reference product capsules + 1 placebo tablet | Dietary Supplement: Reference product<br>* Total duration of the study was 4 months; each subject, took by mouth two capsules/die of reference product at breakfast and one tablet/die of placebo at lunch for the first 3 months of the trial.<br>|
| Placebo Comparator: PLACEBO<br>2 placebo capsules + 1 placebo tablet | Dietary Supplement: Placebo<br>* Total duration of the study was 4 months; each subject, took by mouth two capsules/die of placebo at breakfast and one tablet/die of placebo at lunch for the first 3 months of the trial.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of the percentage of hair in anagen phase | 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. | Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4). | 
| Change from baseline of the hair density | Hair density (hair number/cm2) was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope. | Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4). | 
| Change from baseline of the percentage of vellus hair | 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. | Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair parting test | Evaluation of hair thickening | 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). | 
| Videodermatoscopy | Evaluation to visualize any morphological alteration/variation of the hair often imperceptible to the naked eye | 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 | Evaluation of tensile strength of the hair | 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 | Measurement of surface lipid level | 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). |