AlopeciaGLP-1NCT07783113
Dietary Supplement for Telogen Effluvium Associated With GLP-1 Receptor Agonist Use
A study testing Dietary Supplement for Hair Loss in people with Alopecia, run by Farmoquimica S.A. at 1 site in Brazil.
Trial summary
A single-center, open-label clinical study to evaluate whether a dietary supplement can reduce hair loss in women with GLP-1-associated telogen effluvium. Participants will use the supplement for 120 days. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alopecia
- What is being tested?
- Dietary Supplement for Hair Loss
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female participants aged 20 to 60 years.
- Dry, normal, combination, or oily scalp type.
- Clinical diagnosis of telogen effluvium associated with the use of GLP-1 receptor agonists (semaglutide or tirzepatide), diagnosed by a dermatologist and confirmed by trichogram analysis.
- Hair length of at least 3 cm.
- Use of GLP-1 receptor agonists (semaglutide or tirzepatide) for at least 3 months prior to enrollment.
- Intact skin in the study area (scalp).
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- Use of GLP-1 receptor agonists approved by ANVISA and commercially available in Brazil.
- Under regular medical supervision during the study period.
- Loss of at least 5% of initial body weight prior to enrollment.
- Willingness to maintain the same hairstyle, haircut, and hair care habits throughout the study.
- Willingness to comply with all study procedures and requirements.
- Ability to provide written informed consent.
Who cannot join
- Pregnancy, breastfeeding, postpartum period up to 6 months, or intention to become pregnant during the study.
- Scalp conditions or skin marks that may interfere with study assessments.
- Known allergy or hypersensitivity to any component of the investigational product or similar products.
- Active scalp disorders that could interfere with study evaluations, including scarring alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate-to-severe seborrheic dermatitis, or eczema.
- Use of nonsteroidal anti-inflammatory drugs, corticosteroids, antihistamines, photosensitizing agents, or immunosuppressants within 2 weeks before enrollment.
- Ongoing radiotherapy or chemotherapy treatment.
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- Hair chemical procedures within 30 days prior to enrollment.
- Recent use or dose adjustment of medications known to induce telogen effluvium.
- Use of dietary supplements for hair loss within the previous 3 months.
- Use of hair loss treatments or hair cycle modulators (e.g., minoxidil, finasteride, dutasteride, spironolactone) within the previous 3 months.
- Hair transplantation within the previous 18 months.
- Use of topical dermatological products for therapeutic or specific cosmetic purposes on the study area (scalp), such as hair tonics, topical minoxidil, medicated lotions, or acid-based treatments, within 48 hours prior to study initiation.
- Initiation, discontinuation, or modification of hormone therapy within the previous 3 months.
- Uncontrolled systemic diseases, including diabetes, lupus, thyroid disorders, anemia, or documented iron deficiency.
- Bariatric surgery within the previous 12 months.
- Hair loss associated with COVID-19 infection within the previous 6 months.
- Hospitalization within the previous 6 months.
- Major physical or psychological stressors within the previous 3 months.
- Uncontrolled endocrine disorders.
- History or evidence of alcohol or substance abuse.
- Immunosuppression caused by medications or active diseases.
- Excessive sun exposure or artificial tanning within 15 days before the baseline visit.
- Participation in another clinical study.
- Investigator site staff or family members directly involved in the study.
- Any condition that, in the investigator's opinion, may compromise participant safety or study integrity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Kosmoscience Ciência E Tecnologia Cosmética - Ltda
São Paulo, São Paulo, 13270-180
Adriano S da Silva Pinheiro, BSc, +55 19 3829 - 3482, adriano@kosmoscience.com
Ana Lúcia T Tabarini Alves Pinheiro, MD
About this study
Official title: Estudo da eficácia de um Suplemento Alimentar na redução da Queda Capilar em Participantes Com eflúvio telógeno Associado ao Uso de análogos de GLP-1 Por Meio de avaliação clínica, percepção Subjetiva e Tricograma
A single-center, open-label clinical study to evaluate whether a dietary supplement can reduce hair loss in women with GLP-1-associated telogen effluvium. Participants will use the supplement for 120 days. Researchers will evaluate hair loss, hair density, and hair growth through clinical assessments, hair measurements (trichogram), and participant questionnaires.
Read the detailed description
This prospective, single-center, open-label, interventional clinical study is designed to evaluate the efficacy and safety of a dietary supplement in women with telogen effluvium associated with the use of GLP-1 receptor agonists. A total of 48 female participants aged 20 to 60 years will be enrolled. Participants will receive the dietary supplement once daily for 120 days and will attend five study visits at baseline (Day 0) and after 30, 60, 90, and 120 days of supplementation.
The study is based on the hypothesis that nutritional supplementation may help improve hair growth cycle dynamics and reduce hair shedding in participants experiencing GLP-1-associated telogen effluvium. Efficacy will be evaluated using a combination of instrumental, clinical, and participant-reported assessments.
Instrumental evaluation will be performed through trichogram analysis at baseline, Day 60, and Day 120 to assess the distribution of hairs in the anagen and telogen phases and the anagen-to-telogen (A:T) ratio. Clinical assessments will be performed by a dermatologist at each visit using a Visual Analog Scale (VAS) to evaluate hair density, scalp coverage, and hair thinning. Participant-reported outcomes will be collected through structured questionnaires designed to assess perceived changes in hair shedding, hair growth, hair volume, hair strength, hair quality, and overall hair appearance during the supplementation period.
Safety and tolerability will be monitored throughout the study through the collection and evaluation of adverse events. Product adherence will be assessed through participant diaries and product accountability records. The study aims to generate clinical evidence regarding the effects of dietary supplementation on hair loss associated with GLP-1 receptor agonist use under real-world conditions.
- Conditions
- Alopecia
- Being tested
- Dietary Supplement for Hair Loss
- Keywords
- Alopecia, Glucagon-Like Peptide-1 Receptor Agonists, Hair loss, Dietary Supplement
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement for Hair LossDietary supplement
Dietary supplement containing vitamins, minerals, amino acids, and silicon intended to support hair health and reduce hair loss.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement | Experimental | Female participants with GLP-1-associated telogen effluvium will receive a dietary supplement once daily for 120 days. Efficacy will be evaluated through trichogram analysis, clinical assessments, and participant questionnaires, with safety monitored during the study. Receives: Dietary Supplement: Dietary Supplement for Hair Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anagen-to-Telogen Hair Ratio (A:T)
Change in the anagen-to-telogen hair ratio (A:T), assessed by trichogram analysis after 120 days of supplementation with a dietary supplement, compared with baseline (Day 0), in women with telogen effluvium associated with the use of GLP-1 receptor agonists.
Measured: Baseline and Day 120
Secondary outcomes (9)
Anagen-to-Telogen Hair Ratio (A:T) at Day 60
Change in the anagen-to-telogen hair ratio (A:T), assessed by trichogram analysis after 60 days of supplementation with a dietary supplement, compared with baseline (Day 0).Baseline and Day 60
Measured: Baseline and Day 60
Change in hair thinning score assessed by Visual Analog Scale (VAS)
Change from baseline in hair thinning score assessed using a 100-mm Visual Analog Scale, where 0 mm indicates absence of hair thinning and 100 mm indicates intense hair thinning. Lower scores represent a better outcome. Assessments will be performed after 30, 60, 90, and 120 days of supplementation.
Measured: Baseline, Day 30, Day 60, Day 90, and Day 120
Incidence of Adverse Events
Occurrence of adverse events reported during 120 days of continuous use of the investigational product, including assessment of their nature, severity, and relationship to the investigational product.
Measured: Day 30, Day 60, Day 90, and Day 120
Change in hair density score assessed by Visual Analog Scale (VAS)
Change from baseline in hair density score assessed using a 100-mm Visual Analog Scale, where 0 mm indicates absence of hair density and 100 mm indicates intense hair density. Higher scores represent a better outcome. Assessments will be performed after 30, 60, 90, and 120 days of supplementation.
Measured: Baseline, Day 30, Day 60, Day 90, and Day 120
Change in perceived hair shedding assessed by a self-perception questionnaire
Change from baseline in participant-perceived hair shedding assessed using a structured self-perception questionnaire. Responses are recorded on a 5-point Likert scale, where 1 = Strongly Disagree, 2 = Disagree, 3 = Neither Agree nor Disagree, 4 = Agree, and 5 = Strongly Agree. Higher scores indicate greater perceived improvement in hair shedding. The frequency and percentage of responses for each score category will be summarized.
Measured: Baseline, Day 30, Day 60, Day 90, and Day 120
Change in perceived hair strength assessed by a self-perception questionnaire
Change from baseline in participant-perceived hair strength assessed using a structured self-perception questionnaire. Responses are recorded on a 5-point Likert scale, where 1 = Strongly Disagree, 2 = Disagree, 3 = Neither Agree nor Disagree, 4 = Agree, and 5 = Strongly Agree. Higher scores indicate greater perceived improvement in hair strength. The frequency and percentage of responses for each score category will be summarized.
Measured: Baseline, Day 30, Day 60, Day 90, and Day 120
Change in perceived hair volume assessed by a self-perception questionnaire
Change from baseline in participant-perceived hair volume assessed using a structured self-perception questionnaire. Responses are recorded on a 5-point Likert scale, where 1 = Strongly Disagree, 2 = Disagree, 3 = Neither Agree nor Disagree, 4 = Agree, and 5 = Strongly Agree. Higher scores indicate greater perceived improvement in hair volume. The frequency and percentage of responses for each score category will be summarized.
Measured: Baseline, Day 30, Day 60, Day 90, and Day 120
Change in perceived hair breakage assessed by a self-perception questionnaire
Change from baseline in participant-perceived hair breakage assessed using a structured self-perception questionnaire. Responses are recorded on a 5-point Likert scale, where 1 = Strongly Disagree, 2 = Disagree, 3 = Neither Agree nor Disagree, 4 = Agree, and 5 = Strongly Agree. Higher scores indicate lower perceived hair breakage and greater improvement in hair resistance. The frequency and percentage of responses for each score category will be summarized.
Measured: Baseline, Day 30, Day 60, Day 90, and Day 120
Change in perceived overall hair appearance assessed by a self-perception questionnaire
Change from baseline in participant-perceived overall hair appearance assessed using a structured self-perception questionnaire. Responses are recorded on a 5-point Likert scale, where 1 = Strongly Disagree, 2 = Disagree, 3 = Neither Agree nor Disagree, 4 = Agree, and 5 = Strongly Agree. Higher scores indicate greater perceived improvement in the overall appearance of the hair. The frequency and percentage of responses for each score category will be summarized.
Measured: Baseline, Day 30, Day 60, Day 90, and Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Farmoquimica S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kosmoscience Ciência e Tecnologia Cosmética Ltda
- Responsible party
- Sponsor
- Investigators
- Ana Lúcia T Tabarini Alves Pinheiro, MD, Principal investigator, Kosmoscience Ciência e Tecnologia Cosmética Ltda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783113
- Sponsor's protocol ID
- FQM263-26
- Acronym
- GLP-1
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a preliminary, exploratory clinical study evaluating a dietary supplement intended to support hair health in individuals with telogen effluvium associated with the use of GLP-1 receptor agonists. Individual participant data are not planned to be shared. If the study results are selected for publication, aggregate findings will be reported and made publicly available as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estudo da eficácia de um Suplemento Alimentar na redução da Queda Capilar em Participantes Com eflúvio telógeno Associado ao Uso de análogos de GLP-1 Por Meio de avaliação clínica, percepção Subjetiva e Tricograma
- ClinicalTrials.gov ID
- NCT07783113
- Acronym / sponsor ID
- GLP-1 / FQM263-26
- Conditions
- Alopecia
- Keywords
- Alopecia, Glucagon-Like Peptide-1 Receptor Agonists, Hair loss, Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Farmoquimica S.A.Industry (pharma, biotech, devices)
- Collaborators
- Kosmoscience Ciência e Tecnologia Cosmética Ltda
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Aug 2026 (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 single-center, open-label clinical study to evaluate whether a dietary supplement can reduce hair loss in women with GLP-1-associated telogen effluvium. Participants will use the supplement for 120 days. Researchers will evaluate hair loss, hair density, and hair growth through clinical assessments, hair measurements (trichogram), and participant questionnaires.
Detailed description
This prospective, single-center, open-label, interventional clinical study is designed to evaluate the efficacy and safety of a dietary supplement in women with telogen effluvium associated with the use of GLP-1 receptor agonists. A total of 48 female participants aged 20 to 60 years will be enrolled. Participants will receive the dietary supplement once daily for 120 days and will attend five study visits at baseline (Day 0) and after 30, 60, 90, and 120 days of supplementation.
The study is based on the hypothesis that nutritional supplementation may help improve hair growth cycle dynamics and reduce hair shedding in participants experiencing GLP-1-associated telogen effluvium. Efficacy will be evaluated using a combination of instrumental, clinical, and participant-reported assessments.
Instrumental evaluation will be performed through trichogram analysis at baseline, Day 60, and Day 120 to assess the distribution of hairs in the anagen and telogen phases and the anagen-to-telogen (A:T) ratio. Clinical assessments will be performed by a dermatologist at each visit using a Visual Analog Scale (VAS) to evaluate hair density, scalp coverage, and hair thinning. Participant-reported outcomes will be collected through structured questionnaires designed to assess perceived changes in hair shedding, hair growth, hair volume, hair strength, hair quality, and overall hair appearance during the supplementation period.
Safety and tolerability will be monitored throughout the study through the collection and evaluation of adverse events. Product adherence will be assessed through participant diaries and product accountability records. The study aims to generate clinical evidence regarding the effects of dietary supplementation on hair loss associated with GLP-1 receptor agonist use under real-world conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | Experimental | Dietary Supplement: Dietary Supplement for Hair LossFemale participants with GLP-1-associated telogen effluvium will receive a dietary supplement once daily for 120 days. Efficacy will be evaluated through trichogram analysis, clinical assessments, and participant questionnaires, with safety monitored during the study. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Female participants aged 20 to 60 years.
- Dry, normal, combination, or oily scalp type.
- Clinical diagnosis of telogen effluvium associated with the use of GLP-1 receptor agonists (semaglutide or tirzepatide), diagnosed by a dermatologist and confirmed by trichogram analysis.
- Hair length of at least 3 cm.
- Use of GLP-1 receptor agonists (semaglutide or tirzepatide) for at least 3 months prior to enrollment.
Key exclusion criteria (25 listed)
- Pregnancy, breastfeeding, postpartum period up to 6 months, or intention to become pregnant during the study.
- Scalp conditions or skin marks that may interfere with study assessments.
- Known allergy or hypersensitivity to any component of the investigational product or similar products.
- Active scalp disorders that could interfere with study evaluations, including scarring alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate-to-severe seborrheic dermatitis, or eczema.
- Use of nonsteroidal anti-inflammatory drugs, corticosteroids, antihistamines, photosensitizing agents, or immunosuppressants within 2 weeks before enrollment.
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 |
|---|---|---|
| Dietary Supplement for Hair LossDietary supplement containing vitamins, minerals, amino acids, and silicon intended to support hair health and reduce hair loss. | Dietary supplement | Dietary Supplement |
Primary outcome
Anagen-to-Telogen Hair Ratio (A:T)
Time frame: Baseline and Day 120
Change in the anagen-to-telogen hair ratio (A:T), assessed by trichogram analysis after 120 days of supplementation with a dietary supplement, compared with baseline (Day 0), in women with telogen effluvium associated with the use of GLP-1 receptor agonists.
9 secondary outcomes
Anagen-to-Telogen Hair Ratio (A:T) at Day 60
Time frame: Baseline and Day 60
Change in hair thinning score assessed by Visual Analog Scale (VAS)
Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120
Incidence of Adverse Events
Time frame: Day 30, Day 60, Day 90, and Day 120
Change in hair density score assessed by Visual Analog Scale (VAS)
Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120
Change in perceived hair shedding assessed by a self-perception questionnaire
Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120
Change in perceived hair strength assessed by a self-perception questionnaire
Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120
Change in perceived hair volume assessed by a self-perception questionnaire
Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120
Change in perceived hair breakage assessed by a self-perception questionnaire
Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120
Change in perceived overall hair appearance assessed by a self-perception questionnaire
Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Undecided. This is a preliminary, exploratory clinical study evaluating a dietary supplement intended to support hair health in individuals with telogen effluvium associated with the use of GLP-1 receptor agonists. Individual participant data are not planned to be shared. If the study results are selected for publication, aggregate findings will be reported and made publicly available as appropriate.
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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.
Ana Lúcia T Tabarini Alves Pinheiro, MD principal investigator
Kosmoscience Ciência e Tecnologia Cosmética Ltda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Supplement for Hair Loss in people with Alopecia, 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 12 inclusion and 25 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: opening soon, as of the sponsor's last update on 27 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernanda C Calvente Bayan, BSc (+55 21 97273-2295, fbayan@fqm.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anagen-to-Telogen Hair Ratio (A:T) (time frame: Baseline and Day 120). 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 27 Aug 2026.