CClinicalTrials.gg
CompletedNCT06545552Updated Jun 5, 2025

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

An interventional study of An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeast and Placebo in Telogen Effluvium and Healthy, sponsored by Activ'inside. Completed at 1 site in Italy. Open to female participants aged 18 Years to 52 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-05.

Sponsored by Activ'inside · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 52 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Telogen Effluvium
  • Healthy

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03

In context

Alopecia Areata

467 studies on the registry are indexed under Alopecia Areata; 92 are open to participants now.

This study's enrollment of 66 is above the median of 50 across 380 interventional studies indexed under Alopecia Areata.

Browse Alopecia Areata studies →

Lead sponsor

Activ'inside is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 52 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
66 participants (actual)

Study arms

  • 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

  • Placebo comparator
    Placebo

    Hard shell capsule containing maltodextrine

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementAn oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeast

    Hard shell capsule containing 280mg of the oral formulation

  • Dietary supplementPlacebo

    Hard shell capsule containing maltodextrine

06

What researchers measure

Primary outcomes

  1. Change in Anagen hair density

    Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)

    Time frame: after 84 days of supplementation

Secondary outcomes

  1. Change in hair brightness

    8° gloss value (average value of 5 measures) using spectrophotometer/colorimeter CM 700D (Konica-Minolta).

    Time frame: after 42 and 84 days of supplementation

  2. Change in hair elasticity

    using a dynamometer (Tensolab 2512A, Mesdan Lab)

    Time frame: after 42 and 84 days of supplementation

  3. Change in hair volume

    Using a 7-point scale administred by a dermatologist

    Time frame: after 42 and 84 days of supplementation

  4. Change in hair loss

    Number of extracted hairs using a pull test

    Time frame: after 42 and 84 days of supplementation

  5. Change in Total Hair Density

    Number of total hairs per cm² using phototricogram (TrichoScan)

    Time frame: after 42 and 84 days of supplementation

  6. Change in Telogene Hair Density

    Number of hairs in telogen phase per cm² and proportion (in %) using phototricogram (TrichoScan)

    Time frame: after 42 and 84 days of supplementation

  7. Change in Anagen hair density

    Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)

    Time frame: after 42 days of supplementation

07

Study locations

1 site
  • Complife Italia srl
    San Martino Siccomario, 27028, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06545552
Lead sponsor
Activ'inside
Collaborators
Complife Italia Srl
Responsible party
Sponsor
First posted
Aug 9, 2024
Start date
Sep 30, 2024
Primary completion
Jan 24, 2025
Completion
Jan 24, 2025
Last update
Jun 5, 2025

Study contacts

Gloria Roveda, MD, PhD
principal investigator · Complife Italia srl Via Mons. Angelini, 21 27028 San Martino Siccomario (PV)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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