Health TrialsbyHealthPanel

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

ConditionAlopecia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-60
SponsorFarmoquimica S.A.

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Dietary SupplementExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Farmoquimica S.A.

Lead sponsor

Kosmoscience Ciência e Tecnologia Cosmética Ltda

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: