Hair LossNCT05945979
Evaluation of the Efficacy of a New Supplement for Hair and Nails - in Vitro, Clinical, Subjective and Instrumental Study
A study testing A power supplement with biotin in people with Hair Loss and Nails, Ingrown, run by Farmoquimica S.A. at 1 site in Brazil.
Trial summary
A unicentric, exploratory, prospective clinical an in vitro study to evaluate efficacy and safety of a Supplement in improving the quality and general aspects of hair and nails in female participants through clinical,in vitro, subjective and instrumental evaluations Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hair Loss, Nails, Ingrown
- What is being tested?
- A power supplement with biotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Mar 2022to 1 Jun 2022
- 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Phototype (Fitzpatrick): I to VI.
- Have intact skin in the test region: scalp.
- Present a clinical diagnosis of telogen effluvium.
- Agree to adhere to the study procedures and requirements: study time, returns (D-3, D0, D45, D48,D90 and D93) to the laboratory to carry out the study procedures, administration of the product research, fill the use diary, fill the perceived efficacy questionnaire, carrying out the collection of hair samples (hair cut, close to the scalp - beginning of the study and after 90 days), not change hair habits during the study period.
- Agree not to carry out chemical hair treatments (hair coloring, straightening, among others) and/or treatment to control/reduce hair loss and/or dandruff, among others, until the end of the study (90 days).
- Agree with the procedure for collecting hair samples: trichogram and hair cut, close to the leather hairy.
Show all 9Show fewer
- Agree to administer 01 capsule/day of the investigational product. Present a minimum length of hair (3 cm) to carry out the procedure for collecting samples of hair
- Present hair and brittleness for at least 3 months before the start of the study.
- Signature of the Free and Informed Consent Term (TCLE).
Who cannot join
- Pregnancy
- During the course of the study, the subject develops symptoms of COVID-19, such as: fever (temperature above 37.5°C), cough; dyspnoea (difficulty breathing characterized by rapid, short breaths, usually associated with heart or lung disease); myalgia (muscle pain); upper respiratory symptoms; fatigue and more rarely, gastrointestinal symptoms.
- Appearance of disease that requires the use of medications prohibited in this protocol: use of corticoids and anti-inflammatories for a period longer than 15 days and/or in high doses (above 1mg/kg).
- Use of immunosuppressants during the study period.
- Use of Vitamin A or its derivatives and other vitamins and minerals.
- Beginning or changing hormone treatments after signing the TCLE.
Show all 11Show fewer
- Swallowing difficulty: dysphagia.
- Presence of dermatoses or active skin lesions (local and/or disseminated) in the study region.
- Hypersensitivity reactions (allergic reactions, irritation or feelings of discomfort) caused by actives or excipients from the investigational product.
- Vaccine use during the study period.
- Diagnosis of diabetes or nephropathies during the study period.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Kosmoscience Ciência e Tecnologia Cosmética Ltda
Valinhos, São Paulo, 13270-180
About this study
Official title: Avaliação da eficácia de um Novo Suplemento Alimentar Para Cabelos e Unhas- Estudo in Vitro, clínico, Subjetivo e Instrumental
A unicentric, exploratory, prospective clinical an in vitro study to evaluate efficacy and safety of a Supplement in improving the quality and general aspects of hair and nails in female participants through clinical,in vitro, subjective and instrumental evaluations
Read the detailed description
A unicentric, exploratory, prospective clinical an in vitro study to evaluate efficacy and safety of a Supplement in improving the quality and general aspects of hair and nails in female participants through clinical, in vitro, subjective and instrumental evaluations.
It will be necessary 40 female participants aged between 25 and 55 years old with a clinical and in vitro diagnosis of telogen effluvium presenting at least one of the following characteristics: hair loss problems caused by stress, poor diet and excess of tinctures and chemicals procedures applied to hair, and menopausal women.
The participants will remain in the study for 93 days using the product. Visits will be scheduled in D-3, D0, D45, D48, D90, D93.
Instrumental evaluations: Evaluated on each visit:
- To analyze the biological cycle of hair growth using Trichogram test - D-3, D45, D90;
- Evaluation of hair growth kinetics using phototrichogram - D-3,D0, D45, D48, D90, D93;
- Evaluation of the mechanical strength of the hair structure using EMIC DL 500- D-3, D90
- Evaluation of the dermal density of the scalp using the high-frequency ultrasound- D-3, D45, D90
- Participants will respond to a subjective assessment using a questionnaire to capture a subjective efficacy- D45, D90
- Conditions
- Hair Loss, Nails, Ingrown
- Being tested
- A power supplement with biotin
- Keywords
- capillary density, strengthening, hair loss
- Medical subject headings
- Alopecia, Nails, Ingrown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A power supplement with biotinDietary supplement
A power dietary supplement containing aminoacids and vitamins
| Study group | Role | What they receive |
|---|---|---|
| A power supplement with biotin | Experimental | 40 participants using the product for 90 days. Aims to evaluate the clinical, subjective and instrumental usage Receives: Dietary Supplement: A power supplement with biotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate efficacy of a power supplement in reducing hair loss throgh thichogram analysis
Evaluate the effectiveness of the product investigational in providing reduction of hair loss through thrichogram analysis. If the ratio between anagen/telogen hairs strands is > 4, it indicates improvement in reducing hair loss after daily and continuous use for a period of up to 90 days.
Measured: Day 93
Secondary outcomes (5)
Analysis of the biological cycle of hair growth- Trichogram
Evaluate the phase of the biological cycle of hair growth (anagen, telogen or catagen) and determine the ratio between anagen/telogen hair strands. If the ratio between anagen/telogen hairs strands is ≤ 4, it indicates positive symptoms for androgenetic alopecia or telogen effluvium and the partipant will be included in the study.The trichogram was performed three days before the beginning of product intake, and after 45 days and 90 days of continuous use.
Measured: Three days before the beginning of product intake, Day 45 and Day 90
Evaluation of hair growth kinetics- Phototrichogram
Evaluate the growth kinetics of hair strands after shaving a standardized area of 1 cm² of the scalp and taking images on the same day and three days after. In total, three scrapings were performed on three days before intervention, day 45 and day 90, totaling six image collections. A microscope (i-Scope USB, Moritex, JP) with a 30x lens and polarized light was used to obtain the images. In each collection, three microimages of the evaluated area on the head of each participant were recorded.
Measured: Three days before the beginning of product intake, Day 0, Day 45, Day 48, Day 90 and Day 93
Monitoring of hair growth by photographic documentation
Evaluation of the dermal thickness of hair strands through specific software. Patients will be submitted to the Ultrascan UC 22 MHz equipment (Courage + Khazaka electronic GmbH), on day 0 and after 45 days and 90 days of continuous use of the investigational product.
Measured: Day 0, Day 45 and Day 90
Evaluation of the mechanical strength of the hair structure using EMIC DL 500
Evaluation of the mechanical resistance of the hair. 50 hairs strands were collected from each participant and cut with the aid of scissors to avoid possible damage to the hair shaft resulting from traction for pulling out. The test was performed three days before the beginning of product intake and after 90 days of continuous use.
Measured: Three days before the beginning of product intake and Day 90
Subjective efficacy of the participants by questionnaire
Evaluate the perceived efficacy of the product from the participant's point of view through a subjective questionnaire after 45 days e 90 days of continuous use of the product. The questionnaire uses a 7-point scale, where 1 meaning poor and 7 means excellent.
Measured: Day 45 and Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start7 Mar 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair LossStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Farmoquimica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kosmoscience Ciência e Tecnologia Cosmética Ltda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945979
- Sponsor's protocol ID
- FQM166-20
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avaliação da eficácia de um Novo Suplemento Alimentar Para Cabelos e Unhas- Estudo in Vitro, clínico, Subjetivo e Instrumental
- ClinicalTrials.gov ID
- NCT05945979
- Acronym / sponsor ID
- FQM166-20
- Conditions
- Hair Loss, Nails, Ingrown
- Keywords
- capillary density, strengthening, hair loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Farmoquimica S.A.Industry (pharma, biotech, devices)
- Collaborators
- Kosmoscience Ciência e Tecnologia Cosmética Ltda
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 14 Jul 2023 (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.
A unicentric, exploratory, prospective clinical an in vitro study to evaluate efficacy and safety of a Supplement in improving the quality and general aspects of hair and nails in female participants through clinical,in vitro, subjective and instrumental evaluations
Detailed description
A unicentric, exploratory, prospective clinical an in vitro study to evaluate efficacy and safety of a Supplement in improving the quality and general aspects of hair and nails in female participants through clinical, in vitro, subjective and instrumental evaluations.
It will be necessary 40 female participants aged between 25 and 55 years old with a clinical and in vitro diagnosis of telogen effluvium presenting at least one of the following characteristics: hair loss problems caused by stress, poor diet and excess of tinctures and chemicals procedures applied to hair, and menopausal women.
The participants will remain in the study for 93 days using the product. Visits will be scheduled in D-3, D0, D45, D48, D90, D93.
Instrumental evaluations: Evaluated on each visit:
- To analyze the biological cycle of hair growth using Trichogram test - D-3, D45, D90;
- Evaluation of hair growth kinetics using phototrichogram - D-3,D0, D45, D48, D90, D93;
- Evaluation of the mechanical strength of the hair structure using EMIC DL 500- D-3, D90
- Evaluation of the dermal density of the scalp using the high-frequency ultrasound- D-3, D45, D90
- Participants will respond to a subjective assessment using a questionnaire to capture a subjective efficacy- D45, D90
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A power supplement with biotin | Experimental | Dietary Supplement: A power supplement with biotin40 participants using the product for 90 days. Aims to evaluate the clinical, subjective and instrumental usage |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Phototype (Fitzpatrick): I to VI.
- Have intact skin in the test region: scalp.
- Present a clinical diagnosis of telogen effluvium.
- Agree to adhere to the study procedures and requirements: study time, returns (D-3, D0, D45, D48,D90 and D93) to the laboratory to carry out the study procedures, administration of the product research, fill the use diary, fill the perceived efficacy questionnaire, carrying out the collection of hair samples (hair cut, close to the scalp - beginning of the study and after 90 days), not change hair habits during the study period.
- Agree not to carry out chemical hair treatments (hair coloring, straightening, among others) and/or treatment to control/reduce hair loss and/or dandruff, among others, until the end of the study (90 days).
Key exclusion criteria (11 listed)
- Pregnancy
- During the course of the study, the subject develops symptoms of COVID-19, such as: fever (temperature above 37.5°C), cough; dyspnoea (difficulty breathing characterized by rapid, short breaths, usually associated with heart or lung disease); myalgia (muscle pain); upper respiratory symptoms; fatigue and more rarely, gastrointestinal symptoms.
- Appearance of disease that requires the use of medications prohibited in this protocol: use of corticoids and anti-inflammatories for a period longer than 15 days and/or in high doses (above 1mg/kg).
- Use of immunosuppressants during the study period.
- Use of Vitamin A or its derivatives and other vitamins and minerals.
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 |
|---|---|---|
| A power supplement with biotinA power dietary supplement containing aminoacids and vitamins | Dietary supplement | A power supplement with biotin |
Primary outcome
Evaluate efficacy of a power supplement in reducing hair loss throgh thichogram analysis
Time frame: Day 93
Evaluate the effectiveness of the product investigational in providing reduction of hair loss through thrichogram analysis. If the ratio between anagen/telogen hairs strands is > 4, it indicates improvement in reducing hair loss after daily and continuous use for a period of up to 90 days.
5 secondary outcomes
Analysis of the biological cycle of hair growth- Trichogram
Time frame: Three days before the beginning of product intake, Day 45 and Day 90
Evaluation of hair growth kinetics- Phototrichogram
Time frame: Three days before the beginning of product intake, Day 0, Day 45, Day 48, Day 90 and Day 93
Monitoring of hair growth by photographic documentation
Time frame: Day 0, Day 45 and Day 90
Evaluation of the mechanical strength of the hair structure using EMIC DL 500
Time frame: Three days before the beginning of product intake and Day 90
Subjective efficacy of the participants by questionnaire
Time frame: Day 45 and Day 90
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 14 Jul 2023.
- Individual participant dataSharing planned: Yes
Related trials for Hair Loss
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A power supplement with biotin in people with Hair Loss and Nails, Ingrown, run by Farmoquimica S.A. at 1 site in Brazil.
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 9 inclusion and 11 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 14 Jul 2023. 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 Brazil. 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. 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?
Evaluate efficacy of a power supplement in reducing hair loss throgh thichogram analysis (time frame: Day 93). 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 14 Jul 2023.