Evaluation of Tolerance and Trichological Efficacy of a Food Supplement

NCT03272750 | Completed

• 1 other identifier: E1416
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

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

Conditions

Telogen Effluvium

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Hair parting test

  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

  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

  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

  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).

Study Arms (3)

Bioscalin® new formulation with Galeopsis Segetum

EXPERIMENTAL

2 placebo capsules + 1 Bioscalin with Galeopsis Segetum table

Dietary Supplement: Bioscalin® new formulation with Galeopsis Segetum

REFERENCE PRODUCT

ACTIVE COMPARATOR

2 reference product capsules + 1 placebo tablet

Dietary Supplement: Reference product

PLACEBO

PLACEBO COMPARATOR

2 placebo capsules + 1 placebo tablet

Dietary Supplement: Placebo

Interventions

Bioscalin® new formulation with Galeopsis Segetum 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.

Bioscalin® new formulation with Galeopsis Segetum

Reference product 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.

REFERENCE PRODUCT

Placebo 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.

PLACEBO

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• both sexes;
• age range 18-60 years old;
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Derming SRL: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatologist, Principal Investigator

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 6, 2017
• Study Start: November 4, 2016
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: September 6, 2017

Record last verified: 2017-09