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

NCT07783113 | Not Yet Recruiting

• 1 other identifier: FQM263-26
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alopecia

Keywords

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

Outcome Measures

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.

  Baseline and Day 120

Secondary Outcomes (9)

• Anagen-to-Telogen Hair Ratio (A:T) at Day 60

  Baseline and Day 60

• Change in hair thinning score assessed by Visual Analog Scale (VAS)

  Baseline, Day 30, Day 60, Day 90, and Day 120

• Incidence of Adverse Events

  Day 30, Day 60, Day 90, and Day 120

• Change in hair density score assessed by Visual Analog Scale (VAS)

  Baseline, Day 30, Day 60, Day 90, and Day 120

• Change in perceived hair shedding assessed by a self-perception questionnaire

  Baseline, Day 30, Day 60, Day 90, and Day 120

Study Arms (1)

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.

Dietary Supplement: Dietary Supplement for Hair Loss

Interventions

Dietary Supplement for Hair Loss DIETARY_SUPPLEMENT

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

Dietary Supplement

Eligibility Criteria

• Age: 20 Years - 60 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 informed consent.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Farmoquimica S.A.: lead
• Kosmoscience Ciência e Tecnologia Cosmética Ltda: collaborator

Study Sites (1)

Kosmoscience Ciência E Tecnologia Cosmética - Ltda

São Paulo, São Paulo, 13270-180, Brazil

Location

MeSH Terms

Conditions

Alopecia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ana Lúcia T Tabarini Alves Pinheiro, MD

  Kosmoscience Ciência e Tecnologia Cosmética Ltda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda C Calvente Bayan, BSc

CONTACT

+55 21 97273-2295; fbayan@fqm.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

BR (1)