Evaluation of Tolerance and Trichological Efficacy of a Food Supplement

Telogen Effluvium Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272750
• Other study ID #: E1416
• Status: Completed
• Phase: N/A
• First received: September 1, 2017
• Last updated: September 1, 2017
• Start date: November 4, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: September 2017
• Source: Derming SRL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Telogen Effluvium

Intervention

Dietary Supplement:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Derming SRL

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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).