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
NCT Number: NCT07806474
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.
Trial opening soon.
Get Notified35 year–65 year
Male
Interventional
Not applicable
Nutratech S.r.l. - Via Francesco Todaro 20/22, Rende, Cosenza, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 42 and 84 days
Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
Time frame: 42 and 84 days
= (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
Number of hairs in telogen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
Time frame: 42 ans 84 days
(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 and 84 days
Number of total hairs per cm² using phototricogram (TrichoScan)
Time frame: 42 and 84 days
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
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
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.
Contact information is provided by the study sponsor or research team.
Activ'inside
Industry
Clinical Efficacy and Safety of Two Food Supplements on Hair Health in Caucasian Male Subjects With Androgenic Alopecia : a Multicentric, Randomised, Double-blind, Placebo-controlled Clinical Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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