Alopecia
Conditions
Keywords
Alopecia, Glucagon-Like Peptide-1 Receptor Agonists, Hair loss, Dietary Supplement
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.
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.
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.
Sponsors
Farmoquimica S.A.
Kosmoscience Ciência e Tecnologia Cosmética Ltda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anagen-to-Telogen Hair Ratio (A:T) at Day 60 | Baseline and 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 |
| Change in hair thinning score assessed by Visual Analog Scale (VAS) | Baseline, Day 30, Day 60, Day 90, and Day 120 | 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. |
| Incidence of Adverse Events | Day 30, Day 60, Day 90, and Day 120 | 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. |
| Change in hair density score assessed by Visual Analog Scale (VAS) | Baseline, Day 30, Day 60, Day 90, and Day 120 | 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. |
| Change in perceived hair shedding assessed by a self-perception questionnaire | Baseline, Day 30, Day 60, Day 90, and Day 120 | 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. |
| Change in perceived hair strength assessed by a self-perception questionnaire | Baseline, Day 30, Day 60, Day 90, and Day 120 | 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. |
| Change in perceived hair volume assessed by a self-perception questionnaire | Baseline, Day 30, Day 60, Day 90, and Day 120 | 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. |
| Change in perceived hair breakage assessed by a self-perception questionnaire | Baseline, Day 30, Day 60, Day 90, and Day 120 | 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. |
| Change in perceived overall hair appearance assessed by a self-perception questionnaire | Baseline, Day 30, Day 60, Day 90, and Day 120 | 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. |
Countries
Brazil
Contacts
CONTACTFernanda C Calvente Bayan, BSc
PRINCIPAL_INVESTIGATORAna Lúcia T Tabarini Alves Pinheiro, MD
Kosmoscience Ciência e Tecnologia Cosmética Ltda
Outcome results
None listed