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

NCT ID: NCT06545552

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-01-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active product

Hard shell capsule containing 280 mg of active compound.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

Hard shell capsule containing 280mg of the oral formulation

Placebo

Hard shell capsule containing maltodextrine

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Hard shell capsule containing maltodextrine

Interventions

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

Hard shell capsule containing 280mg of the oral formulation

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Hard shell capsule containing maltodextrine

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Complife Italia Srl

INDUSTRY

Sponsor Role: collaborator

Activ'inside

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gloria Roveda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Complife Italia srl

San Martino Siccomario, , Italy

Countries

Italy

Other Identifiers

IT0000642/24 rev. 01

Identifier Type: -

Identifier Source: org_study_id