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

NCT06545552 | Completed

• 1 other identifier: IT0000642/24 rev. 01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Telogen Effluvium; Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in hair brightness

  after 42 and 84 days of supplementation

• Change in hair elasticity

  after 42 and 84 days of supplementation

• Change in hair volume

  after 42 and 84 days of supplementation

• Change in hair loss

  after 42 and 84 days of supplementation

• Change in Total Hair Density

  after 42 and 84 days of supplementation

Study Arms (2)

Active product

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Hard shell capsule containing maltodextrine

Dietary Supplement: Placebo

Interventions

An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeast DIETARY_SUPPLEMENT

Hard shell capsule containing 280mg of the oral formulation

Active product

Placebo DIETARY_SUPPLEMENT

Hard shell capsule containing maltodextrine

Placebo

Eligibility Criteria

• Age: 18 Years - 52 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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
• Scalp surgery (hair transplants, laser) at any time.

Sponsors & Collaborators

• Activ'inside: lead
• Complife Italia Srl: collaborator

Study Sites (1)

Complife Italia srl

San Martino Siccomario, 27028, Italy

Location

Study Officials

• Gloria Roveda, MD, PhD

  Complife Italia srl Via Mons. Angelini, 21 27028 San Martino Siccomario (PV)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 9, 2024
• Study Start: September 30, 2024
• Primary Completion: January 24, 2025
• Study Completion: January 24, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)