Clinical trial NCT03272750: Evaluation of Tolerance and Trichological Efficacy of a Food Supplement
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telogen Effluvium
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline of the percentage of hair in anagen phase
timeFrame: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
measure: Change from baseline of the hair density
timeFrame: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
measure: Change from baseline of the percentage of vellus hair
timeFrame: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
Secondary outcomes:
measure: Hair parting test
timeFrame: 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).
measure: Videodermatoscopy
timeFrame: 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).
measure: Pull test
timeFrame: 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).
measure: Sebometry
timeFrame: 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).
Other outcomes:
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