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Not yet recruitingNCT07783113GLP-1Updated Aug 27, 2026

Dietary Supplement for Telogen Effluvium Associated With GLP-1 Receptor Agonist Use

An interventional study of Dietary Supplement for Hair Loss in Alopecia, sponsored by Farmoquimica S.A.. Not yet recruiting at 1 site in Brazil. Open to female participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Farmoquimica S.A. · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
20 Years to 60 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Alopecia

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Keywords

  • Alopecia
  • Glucagon-Like Peptide-1 Receptor Agonists
  • Hair loss
  • Dietary Supplement
03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's planned enrollment of 48 is close to the median of 50 across 430 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Farmoquimica S.A. is the lead sponsor of 10 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
20 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).
  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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 to any component of the 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, , antihistamines, photosensitizing agents, or within 2 weeks before enrollment.
  • Ongoing radiotherapy or chemotherapy treatment.
  • 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    Dietary Supplement

    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.

    Dietary Supplement: Dietary Supplement for Hair Loss

Interventions

  • Dietary supplementDietary Supplement for Hair Loss

    Dietary supplement containing vitamins, minerals, amino acids, and silicon intended to support hair health and reduce hair loss.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and Day 120

Secondary outcomes

  1. 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

    Time frame: Baseline and Day 60

  2. 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.

    Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120

  3. 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.

    Time frame: Day 30, Day 60, Day 90, and Day 120

  4. 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.

    Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120

  5. 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.

    Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120

  6. 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.

    Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120

  7. 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.

    Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120

  8. 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.

    Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120

  9. 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.

    Time frame: Baseline, Day 30, Day 60, Day 90, and Day 120

07

Study locations

1 site
  • Kosmoscience Ciência E Tecnologia Cosmética - Ltda
    São Paulo, São Paulo 13270-180, Brazil
    • Adriano S da Silva Pinheiro, BSc · Contactadriano@kosmoscience.com · +55 19 3829 - 3482
    • Ana Lúcia T Tabarini Alves Pinheiro, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Feb 2027, 4 months later.

Of 61 industry-sponsored interventional studies with no phase under Alopecia, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 20. This study's planned 4 months is below that.

Counting every sponsor, half of 146 studies reached it within 12 months; a quarter within 6 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2026
First posted
Aug 24, 2026
StartEst.
Oct 2026
Primary completionEst.
Feb 2027
CompletionEst.
Feb 2027
Last update
Aug 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07783113
Lead sponsor
Farmoquimica S.A.
Collaborators
Kosmoscience Ciência e Tecnologia Cosmética Ltda
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Oct 2026 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Aug 27, 2026

Study contacts

Fernanda C Calvente Bayan, BSc
Contact
fbayan@fqm.com.br
+55 21 97273-2295
Ana Lúcia T Tabarini Alves Pinheiro, MD
principal investigator · Kosmoscience Ciência e Tecnologia Cosmética Ltda

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 not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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