Efficacy and Safety of Two Hair Supplements in Men With Androgenic Alopecia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age35-65
SponsorActiv'inside
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Healthy male subjects
Subjects of Caucasian ethnicity
Subjects aged between 35 and 65 years (extremes included)
Subjects with mild to moderate androgenetic alopecia, corresponding to the grade II to III vertex on Hamilton-Norwood scale
Disqualifiers
Subjects who do not meet the inclusion criteria
Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the Principal Investigator considers dangerous to the subject or incompatible with the requirements of the study **
Subjects participating or planning to participate in other clinical trials
Subjects who participated in a similar study without respecting an adequate washout period (at least one month)
Trial design
Design model
Parallel
Treatments tested in this trial
formulation of green tea leaf extract, bamboo shoot extract and selenium-enriched yeast
Dietary supplementone capsule per day during breakfast with water for 84 days
formulation of grape seed extract, bamboo shoot extract and selenium-enriched yeast
Dietary supplementone capsule per day during breakfast with water for 84 days
Placebo (maltodextrin)
Dietary supplementone capsule per day during breakfast with water for 84 days
Treatment groups
99 Participants
are divided into 3 treatment groupsGroup A: Active product 1Active comparator 1 intervention
Group B: Active product 2Active comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in anagen hair density
Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
Time frame
42 and 84 daysSecondary outcomes
1
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 days2
Change in telogene hair density
Number of hairs in telogen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
Time frame
42 and 84 days3
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 days4
Change in total hair density
Number of total hairs per cm² using phototricogram (TrichoScan)
Time frame
42 and 84 daysOther outcomes
1
Self-assessment questionnaire
Subjects are asked to reply to a self-assessment questionnaire to assess the efficacy perceived and the pleasantness of the product. Responses are provided spontaneously, without external influence.
Time frame
42 and 84 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: