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Introduction <p>Hair loss is a multifactorial and complex condition influenced by hormonal changes, nutritional deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress. This 6-month study evaluated the hair growth-promoting efficacy and safety of a drinkable nutraceutical (Olistic<sup>©</sup> Women) formulated with standardized ingredients to support hair health through multiple biological pathways.</p> Methods <p>A total of 106 premenopausal female subjects (18–40&#xa0;years) clinically diagnosed with telogen effluvium were randomized in a double-blind manner into the active (<i>n</i> = 53) or placebo (<i>n</i> = 53) arm, taking 1&#xa0;vial (25&#xa0;mL) per day for 6&#xa0;months. The primary endpoint was the increase in hair density from baseline versus placebo assessed by phototrichoscopy using TrichoScan<sup>®</sup>; the secondary endpoints were the change in anagen-to-catagen/telogen (A:C/T) ratio assessed by phototrichogram using TrichoScan<sup>®</sup>, as well as safety and tolerability. This study was reviewed and approved (approval number 20230918-EC48.23) by the Comité de Ética de la Investigación con medicamentos (CEIm) Regional de la Comunidad de Madrid in Madrid, Spain. </p> Results <p>Daily oral supplementation with the active product was well tolerated and resulted in a statistically significant increase in hair density versus placebo at day&#xa0;90 (17.53 ± 2.46 vs 9.56 ± 2.43&#xa0;hairs/cm<sup>2</sup>; <i>P</i> = 0.02) and day&#xa0;180 (27.31 ± 2.61 vs 18.23 ± 2.98&#xa0;hairs/cm<sup>2</sup>; <i>P</i> &lt; 0.01). The A:C/T ratio showed a statistically significant increase from day&#xa0;0 to day&#xa0;180 in the active arm (from 8.20:1 to 14.19:1) versus placebo (from 7.43:1 to 8.76:1) (<i>P</i> &lt; 0.001).</p> Conclusion <p>The tested nutraceutical showed a statistically significant increase in hair density and A:C/T ratio compared to placebo over 6&#xa0;months in premenopausal women with telogen effluvium. These results not only support efficacy and safety of the tested nutraceutical but also that a multifactorial nutraceutical approach can effectively manage telogen effluvium in premenopausal women.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT07111312 (retrospectively registered 07/2025).</p>

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Efficacy and Safety of a Drinkable Nutraceutical in Premenopausal Women with Telogen Effluvium: A 6-Month, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月25日

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  • Claudia Bernárdez,
  • Sebastian Podlipnik,
  • Gillian E. Westgate,
  • Ralf Paus,
  • Laura Zamfir,
  • Daniela Grohmann,
  • Manuel Sáez Moya

摘要

Introduction

Hair loss is a multifactorial and complex condition influenced by hormonal changes, nutritional deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress. This 6-month study evaluated the hair growth-promoting efficacy and safety of a drinkable nutraceutical (Olistic© Women) formulated with standardized ingredients to support hair health through multiple biological pathways.

Methods

A total of 106 premenopausal female subjects (18–40 years) clinically diagnosed with telogen effluvium were randomized in a double-blind manner into the active (n = 53) or placebo (n = 53) arm, taking 1 vial (25 mL) per day for 6 months. The primary endpoint was the increase in hair density from baseline versus placebo assessed by phototrichoscopy using TrichoScan®; the secondary endpoints were the change in anagen-to-catagen/telogen (A:C/T) ratio assessed by phototrichogram using TrichoScan®, as well as safety and tolerability. This study was reviewed and approved (approval number 20230918-EC48.23) by the Comité de Ética de la Investigación con medicamentos (CEIm) Regional de la Comunidad de Madrid in Madrid, Spain.

Results

Daily oral supplementation with the active product was well tolerated and resulted in a statistically significant increase in hair density versus placebo at day 90 (17.53 ± 2.46 vs 9.56 ± 2.43 hairs/cm2; P = 0.02) and day 180 (27.31 ± 2.61 vs 18.23 ± 2.98 hairs/cm2; P < 0.01). The A:C/T ratio showed a statistically significant increase from day 0 to day 180 in the active arm (from 8.20:1 to 14.19:1) versus placebo (from 7.43:1 to 8.76:1) (P < 0.001).

Conclusion

The tested nutraceutical showed a statistically significant increase in hair density and A:C/T ratio compared to placebo over 6 months in premenopausal women with telogen effluvium. These results not only support efficacy and safety of the tested nutraceutical but also that a multifactorial nutraceutical approach can effectively manage telogen effluvium in premenopausal women.

Trial Registration

ClinicalTrials.gov identifier, NCT07111312 (retrospectively registered 07/2025).