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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Telogen Effluvium
- Sponsor
- Derming SRL
- Enrollment
- 51
- Primary Endpoint
- Change from baseline of the percentage of hair in anagen phase
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Adele Sparavigna
Dermatologist, Principal Investigator
Derming SRL
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.).
Outcomes
Primary Outcomes
Change from baseline of the percentage of hair in anagen phase
Time Frame: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
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.
Change from baseline of the hair density
Time Frame: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
Hair density (hair number/cm2) was calculate by TrichoScan software on the microscopic images (with 20X magnification) captured with FotoFinderDermoscope.
Change from baseline of the percentage of vellus hair
Time Frame: Basal visit (T0),1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4).
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.
Secondary Outcomes
- 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).)
- 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).)