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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
48
Dietary supplement containing vitamins, minerals, amino acids, and silicon intended to support hair health and reduce hair loss.
Kosmoscience Ciência E Tecnologia Cosmética - Ltda
São Paulo, São Paulo, Brazil
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
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
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
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
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
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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
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
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
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
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