Status:
COMPLETED
Evaluation of Tolerance and Trichological Efficacy of a Food Supplement
Lead Sponsor:
Derming SRL
Conditions:
Telogen Effluvium
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ma...
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 4 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2017
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT03272750
Start Date
November 4 2016
End Date
March 31 2017
Last Update
September 6 2017
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