According to the American Hair Loss Association, by the age of 35, two-thirds of American men will have some degree of appreciable hair loss, and by the age of 50, approximately 50 to 85% of men will have significant hair thinning. Hair is an essential aspect of human appearance and can have a significant impact on a person's self-esteem, mood and quality of life. Unfortunately, current treatment options can be costly, tedious or painful. They are also associated with numerous side effects. Here, the investigators aimed at evaluating the effect of a new food supplement on hair condition in young men suffering from hair loss. A second goal was to determine tolerability.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months
1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months
Complife Italia S.r.l
Pavia, Italy
Changes from baseline in the number of hair in anagen and telogen phases at day 30 and 86.
The total number of hair (hair density) and the number of hair in the anagen phase will be determined by phototricogram. Briefly, all hairs in a 2 sq cm area are trimmed 1 mm from the skin surface. The hair is dyed and a baseline photograph is taken. After 48h, the same region is photographed again. By comparing with the baseline picture, one can observe as to which hair fibers have grown (follicles in anagen) and which have not (follicles in telogen) and the density of the hair (the number of hairs in the photograph). Anagen hair will be manually counted comparing side by side the photographs taken at each checkpoint and 48 hours after. Telogen hair will be calculated as the difference between the total hair number and the anagen hair number.
Time frame: Day 0, Day 30, Day 86
Changes from baseline in hair radiance (au) at day 28 and day 84
Hair radiance will be measured by spectrophotometry.
Time frame: Day 0, Day 28, Day 84
Changes from baseline in hair elongation (%) at day 28 and day 84
Hair elongation (hair elasticity) will be evaluated by means of dynamometer reading. The dynamometer reading will be done on a single hair fiber. In total 10 hair fibers/participant will be measured.
Time frame: Day 0, Day 28, Day 84
Changes from baseline in hair breakage force (cN) at day 28 and day 84
The force at which the hair breaks (breakage force) will be evaluated by means of dynamometer reading. The dynamometer reading will be done on a single hair fiber. In total 10 hair fibers will be measured.
Time frame: Day 0, Day 28, Day 84
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