Telogen EffluviumNCT06545552
Efficacy and Safety of a Dietary Supplement on Hair Growth and Hair Health in Female With Acute Telogen Effluvium
A study testing An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeast in people with Telogen Effluvium and Healthy, run by Activ'inside at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Telogen Effluvium, Healthy
- What is being tested?
- An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2024to 24 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Telogen Effluvium, Healthy
- Being tested
- An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeast, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeastDietary supplement
Hard shell capsule containing 280mg of the oral formulation
PlaceboDietary supplement
Hard shell capsule containing maltodextrine
| Study group | Role | What they receive |
|---|---|---|
| Active product | Active comparator | Hard shell capsule containing 280 mg of active compound. Receives: Dietary Supplement: An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeast |
| Placebo | Placebo comparator | Hard shell capsule containing maltodextrine Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anagen hair density
Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
Measured: after 84 days of supplementation
Secondary outcomes (7)
Change in hair brightness
8° gloss value (average value of 5 measures) using spectrophotometer/colorimeter CM 700D (Konica-Minolta).
Measured: after 42 and 84 days of supplementation
Change in hair elasticity
using a dynamometer (Tensolab 2512A, Mesdan Lab)
Measured: after 42 and 84 days of supplementation
Change in hair volume
Using a 7-point scale administred by a dermatologist
Measured: after 42 and 84 days of supplementation
Change in hair loss
Number of extracted hairs using a pull test
Measured: after 42 and 84 days of supplementation
Change in Total Hair Density
Number of total hairs per cm² using phototricogram (TrichoScan)
Measured: 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)
Measured: 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)
Measured: after 42 days of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start30 Sep 2024
- Primary completion24 Jan 2025
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Telogen EffluviumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Activ'inside
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Complife Italia Srl
- Responsible party
- Sponsor
- Investigators
- Gloria Roveda, MD, PhD, Principal investigator, Complife Italia srl Via Mons. Angelini, 21 27028 San Martino Siccomario (PV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545552
- Sponsor's protocol ID
- IT0000642/24 rev. 01
- Status last verified
- Jun 2025
- First submitted
- 30 Jul 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06545552
- Acronym / sponsor ID
- IT0000642/24 rev. 01
- Conditions
- Telogen Effluvium, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Activ'insideIndustry (pharma, biotech, devices)
- Collaborators
- Complife Italia Srl
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active product | Active comparator | Dietary Supplement: An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeastHard shell capsule containing 280 mg of active compound. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboHard shell capsule containing maltodextrine |
Who may qualify
- Ages
- 18 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeastHard shell capsule containing 280mg of the oral formulation | Dietary supplement | Active product |
| PlaceboHard shell capsule containing maltodextrine | Dietary supplement | Placebo |
Primary outcome
Change in Anagen hair density
Time frame: after 84 days of supplementation
Number of hairs in anagen phase per cm² and proportion (in %) using phototricogram (TrichoScan)
7 secondary outcomes
Change in hair brightness
Time frame: after 42 and 84 days of supplementation
Change in hair elasticity
Time frame: after 42 and 84 days of supplementation
Change in hair volume
Time frame: after 42 and 84 days of supplementation
Change in hair loss
Time frame: after 42 and 84 days of supplementation
Change in Total Hair Density
Time frame: after 42 and 84 days of supplementation
Change in Telogene Hair Density
Time frame: after 42 and 84 days of supplementation
Change in Anagen hair density
Time frame: after 42 days of supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Telogen Effluvium
Not yet recruitingObservational study
Gut Microbiota and Trichoscopic Changes in Women With Telogen Effluvium on a Multifactorial Drinkable Nutraceutical: A Retrospective Observational Study
Gut Dysbiosis, Telogen Effluvium
Recruiting
Efficacy and Safety of a Drinkable Nutraceutical for Hair Loss in Patients Using GLP-1/GIP Receptor Agonists
Telogen Effluvium
Not yet recruiting
Evaluation of the Dietary Supplement Effect on Improvement of Hair Condition in Subjects With Occasional Hair Loss.
Occasional Hair Loss
Not yet recruiting
Dietary Supplement for Telogen Effluvium Associated With GLP-1 Receptor Agonist Use
Alopecia
Not yet recruitingPhase 2/3
Clinical Study of DA-001 as a Treatment for Hair Shedding Reduction and Hair Re-Growth
Telogen Effluvium, Female Pattern Hair Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria Roveda, MD, PhD principal investigator
Complife Italia srl Via Mons. Angelini, 21 27028 San Martino Siccomario (PV)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An oral formulation of green tea extract, bamboo shoot extract and selenium-enriched yeast in people with Telogen Effluvium and Healthy, run by Activ'inside at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anagen hair density (time frame: after 84 days of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.