Evaluation of Tolerance and Trichological Efficacy of a Food Supplement

Derming

Status: Completed

Conditions: Telogen Effluvium

Treatments: Dietary Supplement: Reference product; Dietary Supplement: Placebo; Dietary Supplement: Bioscalin® new formulation with Galeopsis Segetum

Study type: Interventional

Funder types: Other

Identifiers

NCT03272750

E1416

Details and patient eligibility

About

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

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 3 patient groups, including a placebo group

Bioscalin® new formulation with Galeopsis Segetum

Experimental group

Description:

2 placebo capsules + 1 Bioscalin with Galeopsis Segetum table

Treatment:

Dietary Supplement: Bioscalin® new formulation with Galeopsis Segetum

REFERENCE PRODUCT

Active Comparator group

Description:

2 reference product capsules + 1 placebo tablet

Treatment:

Dietary Supplement: Reference product

PLACEBO

Placebo Comparator group

Description:

2 placebo capsules + 1 placebo tablet

Treatment:

Dietary Supplement: Placebo