Efficacy and Safety of a Dietary Supplement on Hair Growth and Hair Health in Female With Acute Telogen Effluvium

Clinical Evaluation of the Efficacy and Safety of a Dietary Supplement on Hair Growth and Hair Health in Female With Acute Telogen Effluvium : a Double-blind, Randomized, Placebo-controlled, Clinical Study

The study is aimed to assess the efficacy of a food supplement in reducing hair loss and accelerating the physiological growth in terms of elongation in female subjects showing acute telogen effluvium. Moreover, the efficacy of the product in increasing hair elasticity, thickness and brightness will be assess.

In order to reach this goal a randomized, double-blind, placebo controlled, parallel group (2 arms), clinical trial is carried out on 66 healthy female subjects aged between 18 and 52 years old, showing acute telogen effluvium will be enrolled.

Study Overview

• Status: Completed
• Conditions: Healthy; Telogen Effluvium
• Intervention / Treatment: Dietary supplement: An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeast; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • San Martino Siccomario, Italy, 27028
    • Complife Italia srl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Good general health
• Caucasian ethnicity
• All hair type included
• Transient acute telogen effluvium (duration less than 6 months) due to fatigue, seasonal change, deficiency of vitamins and minerals, stress, change or imbalance of normal daily routing, or emotional stress
• Subjects having a positive pull test result
• Subjects with minimum hair length of 6/7 cm
• Subjects who stopped any anti hair loss treatment at least 3 months prior the study
• Subjects agreeing not to take any treatment (oral or topic) able to interfere with the hair growth, diameter or fall during the whole study duration
• Willingness not to dye/blench hair during the 2 weeks preceding each visit
• Willingness not to cut hair for all the study length
• Subjects registered with health social security or health social insurance
• Subjects having signed their written Informed Consent form (ICF) and Privacy Policy for their participation in the study and a photograph authorization
• Subjects able to understand the language used in the investigation centre and the information given
• Subjects able to comply with the protocol and follow protocol constraints and specific requirements
• Willingness to use during all the study period only the product to be tested
• Willingness not to use similar products that could interfere with the product to be tested
• Willingness to not vary the normal daily routine (i.e. lifestyle, physical activity, diet etc.)
• Subjects under effective contraception (oral/not oral) if women of childbearing potential; not expected to be changed during the trial

Exclusion Criteria:

• Subjects who do not meet the inclusion criteria
• Subject is taking part or planning to participate to another clinical study in the same or in another investigation centre
• Subject who is deprived of freedom by administrative or legal decision or under guardianship
• Subject admitted in a sanitary or social facilities
• Subject who is planning a hospitalization during the study
• Subjects under treatment with food supplements which could interfere with the functionality of the product under study
• Subject has participated in another clinical study with anti-hair loss product or treatment within the last 24 weeks before the inclusion visit
• Subject breastfeeding, pregnant or not willing to take necessary precautions to avoid pregnancy during the study (if women of childbearing potential)
• Subject has started or changed oestrogen-progesterone contraception or hormonal treatment, within the 3 months prior to the study or foreseeing it for the duration of the study
• Subject having an acute, chronic or progressive illness liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
• Subjects under radiotherapy, chemotherapy at any time
• Subjects under locally pharmacological/non-pharmacological treatment applied on the area of interest monitored during the test
• Subject having food disorders
• Subject who has any other hair disorder or hair disease (female pattern hair loss, any type of alopecia…)
• Subject having excessive and/or fluctuating hair shedding for more than 6 months
• History or clinical signs of hyperandrogenaemia
• Systemic treatment affecting the hair growth taken for more than 4 consecutive weeks during the last 24 weeks before inclusion visit
• Systemic or local androgenetic alopecia treatment or product, taken or applied (Minoxidil, Aminexil, Finasteride, Dutasteride, cosmetic solution or capsules with vitamin B, zinc, caffeine…) for more than 4 consecutive weeks during the last 24 weeks before the inclusion visit
• Any hair care product applied on the scalp between the last shampoo and the inclusion visit (e.g. gel, hairspray, wax, foam…)
• Scalp surgery (hair transplants, laser) at any time.
• Not menopausal women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active product; Hard shell capsule containing 280 mg of active compound.	Dietary supplement: An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeast; Hard shell capsule containing 280mg of the oral formulation
Placebo Comparator: Placebo; Hard shell capsule containing maltodextrine	Dietary supplement: Placebo; Hard shell capsule containing maltodextrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anagen hair density	Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)	after 84 days of supplementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hair brightness	8° gloss value (average value of 5 measures) using spectrophotometer/colorimeter CM 700D (Konica-Minolta).	after 42 and 84 days of supplementation
Change in hair elasticity	using a dynamometer (Tensolab 2512A, Mesdan Lab)	after 42 and 84 days of supplementation
Change in hair volume	Using a 7-point scale administred by a dermatologist	after 42 and 84 days of supplementation
Change in hair loss	Number of extracted hairs using a pull test	after 42 and 84 days of supplementation
Change in Total Hair Density	Number of total hairs per cm² using phototricogram (TrichoScan)	after 42 and 84 days of supplementation
Change in Telogene Hair Density	Number of hairs in telogen phase per cm² and proportion (in %) using phototricogram (TrichoScan)	after 42 and 84 days of supplementation
Change in Anagen hair density	Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)	after 42 days of supplementation

Collaborators and Investigators

• Sponsor: Activ'inside
• Collaborators: Complife Italia Srl
• Investigators: Principal Investigator: Gloria Roveda, MD, PhD, Complife Italia srl Via Mons. Angelini, 21 27028 San Martino Siccomario (PV)

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Actual): January 24, 2025
• Study Completion (Actual): January 24, 2025

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 7, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Alopecia; Hypotrichosis; Hair Diseases; Alopecia Areata; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Trace Elements; Micronutrients; Antioxidants; Protective Agents; Selenium
• Other Study ID Numbers: IT0000642/24 rev. 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No