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Dietary Supplement for Telogen Effluvium Associated With GLP-1 Receptor Agonist Use
Condition(s) studied
Alopecia
Investigational drug(s) / intervention(s)
Dietary Supplement for Hair Loss
Dietary Supplement for Hair Loss: Dietary supplement containing vitamins, minerals, amino acids, and silicon intended to support hair health and reduce hair loss.
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.
Eligibility
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 informed consent.
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 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.
* 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.
Primary outcome measure(s)
- Anagen-to-Telogen Hair Ratio (A:T) — 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.
Trial sites (1)
| Facility | City | Region | Status |
| Kosmoscience Ciência E Tecnologia Cosmética - Ltda |
São Paulo |
São Paulo |
|