The goal of this clinical trial is to evaluate the efficacy and safety of two different formulations of a food supplement on hair health in healthy Caucasian male subjects aged 35 to 65 years with mild to moderate androgenetic alopecia. The main questions it aims to answer are: * Whether the two formulations improve hair growth and reduce hair loss after 42 and 84 days, as assessed by phototricogram parameters. * Whether the two formulations improve hair brightness, and colour lightness after 42 and 84 days, as assessed by spectrophotometer/colorimeter. Researchers will compare two active supplement groups and a placebo group to determine whether the active products improve objective hair parameters and perceived hair quality. Participants will: * be randomized to one of three groups : Active 1, Active 2 or Placebo; * take one capsule daily at breakfast for 84 days; * attend clinical visits at baseline, Day 42, and Day 84; * undergo hair assessments including pull test, phototrichogram, and spectrophotometer/colorimeter measurements; * complete a self-assessment questionnaire at follow-up visits; * be monitored for safety and tolerability throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
99
one capsule per day during breakfast with water for 84 days
one capsule per day during breakfast with water for 84 days
one capsule per day during breakfast with water for 84 days
Nutratech S.r.l. - Via Francesco Todaro 20/22
Rende, Cosenza, Italy
Complife Italia S.r.l. - Via Mortara 171
Ferrara, Ferrare, Italy
Complife Italia S.r.l. - Via Signorelli 159
Garbagnate Milanese, Milan, Italy
Complife Italia S.r.l. - Piazzale Siena 11
Milan, Milan, Italy
Complife Italia SRL - Corso San Maurizio 25
Biella, Pavia, Italy
Complife Italia S.r.l. - Via Monsignor Angelini 21
San Martino Siccomario, Pavia, Italy
Change in anagen hair density
Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
Time frame: 42 and 84 days
Total number of hair in anagen phase
= (Anagen hair after supplement use x scalp surface) - (Anagen hair before supplement use x scalp surface) where the scalp surface is 580 cm2.
Time frame: 42 and 84 days
Change in telogene hair density
Number of hairs in telogen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
Time frame: 42 and 84 days
Number of hair protected against falling out (HPF)
(TEAF x SH) - (TEBE x SH) where: TEAF is the number of telogen hair after supplement use ; TEBE is the number of telogen hair before product use; SH is the head surface (580cm2).
Time frame: 42 ans 84 days
Change in total hair density
Number of total hairs per cm² using phototricogram (TrichoScan)
Time frame: 42 and 84 days
Change in hair brightness
Hair brightness is measured on 5 points near the hairline using a spectrophotometer/colorimeter CM 700D (Konica-Minolta). The measured parameter is the 8° gloss value (average value of the 5 measures).
Time frame: 42 and 84 days
Change in hair colour lightness
Hair color lightness is measured on 5 points near the hairline using a spectrophotometer/colorimeter CM 700D (Konica-Minolta). The measured parameter is the L\* parameter (average value of the 5 measures) indicating the hair color lightness (i.e. lighter or darker hair).
Time frame: 42 and 84 days
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