Evaluation of Tolerance and Trichological Efficacy of a Food Supplement

NCT ID: NCT03272750

Last Updated: 2017-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-04
• Study Completion Date: 2017-03-31

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.

Conditions

Telogen Effluvium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bioscalin® new formulation with Galeopsis Segetum

2 placebo capsules + 1 Bioscalin with Galeopsis Segetum table

Group Type: EXPERIMENTAL

Bioscalin® new formulation with Galeopsis Segetum

Intervention Type: DIETARY_SUPPLEMENT

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.

REFERENCE PRODUCT

2 reference product capsules + 1 placebo tablet

Group Type: ACTIVE_COMPARATOR

Reference product

Intervention Type: DIETARY_SUPPLEMENT

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.

PLACEBO

2 placebo capsules + 1 placebo tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Bioscalin® new formulation with Galeopsis Segetum

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.

Intervention Type: DIETARY_SUPPLEMENT

Reference product

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Derming SRL

OTHER

Sponsor Role: lead

Responsible Party

Adele Sparavigna

Dermatologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

E1416

Identifier Type: -

Identifier Source: org_study_id