Telogen Effluvium
Conditions
Brief summary
The purpose of this clinical trial is to evaluate the efficacy of Olistic© Next Women, a nutraceutical supplement, compared with placebo in improving hair loss in patients undergoing treatment with GLP-1/GIP agonists. This 6-month, randomized, placebo-controlled clinical study investigates whether daily supplementation with Olistic© Next Women leads to significant improvements in hair loss in this patient population. In addition, the study assesses the safety and tolerability of the product throughout the treatment period.
Interventions
DIETARY_SUPPLEMENTDrinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +45.
Drinkable multifactorial food supplement in liquid form, administered once daily in a 25 mL single-dose vial, for a duration of 180 days. The formulation contains a combination of vitamins, minerals, amino acids, plant extracts, and other bioactive compounds designed to support hair growth and scalp health in women +45.
OTHERPlacebo control
Drinkable formulation consisting of an excipient formulation designed to mimic the organoleptic properties of the active product, reproducing its color and texture while achieving a highly similar taste profile.
Sponsors
Olistic Research Labs S.L.
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female gender. * Age \>35 years. * Initiation of treatment with a GLP-1/GIP agonist, or treatment duration \< 3 months, as per routine clinical practice in the endocrinology clinic. * Having signed the participant information sheet and the written informed consent and having been informed of the objective of the study. * Additional criteria to be included by the client.
Exclusion criteria
* Allergy or hypersensitivity to any of the components of the product, or to a product from a similar category to the one being tested. * Scalp diseases: cicatricial alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate to severe seborrheic dermatitis, eczema, cancer, etc. * Women presenting alopecia due to an underlying medical condition (hypothyroidism, anemia, lupus, etc.). * Pharmacological treatment that may promote the onset of telogen effluvium, initiated within the 3 months prior to study start (e.g., valproic acid, carbamazepine, phenytoin, selective serotonin reuptake inhibitors, oral anticoagulants, retinoids, beta-blockers). Patients who have undergone a dose change of these medications within the same period are also excluded. * Women with uncontrolled thyroid disorders (hyperthyroidism or hypothyroidism) within the 6 months prior to study initiation. * Women who have used anti-hair loss products within the last 3 months. * Women who have initiated or undergone dermatological treatment for hair loss within the last 6 months (minoxidil, finasteride, PRP, mesotherapy, etc.). * Women who have undergone hair transplantation within the 18 months prior to study initiation. * Women who have initiated treatment with anxiolytics, antidepressants, amphetamines, ACE inhibitors, or iron within the last 3 months. * Women who initiated or discontinued hormonal treatment (oral contraceptives, oral or topical hormone replacement therapy, ovarian stimulation) within the 3 months prior to study initiation. * Pregnant women, postpartum women (within 6 months), breastfeeding women, or women planning to become pregnant during the study period. * Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hair loss | From baseline to Day 180. | • Patient Reported Outcome using the Hair Shedding Scale: will assess the degree of hair loss among participants. On the day of the visit, they will be shown an A4 sheet with six ranges: between 1 (minimal shedding) to 6 (copious hair shedding). Ref. Perera E and Sinclair R, 2017 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hair loss | From baseline to Day 180. | Comb and Wash Test: this test will quantify the number of fallen hairs (outcome number of shed hairs). It will be carried out after refraining from washing the hair for 48 hours and combing the hair for 24 hours. |
| Body composition | From baseline to Day 180. | Body weight (Kg). Using bioelectrical impedance analysis (BIA) with the Tanita MC-780MA body composition monitor |
| Serum iron level | From baseline to Day 180. | Serum iron concentration measured in blood samples using standard clinical laboratory methods. |
| Ferritin level | From baseline to Day 180. | Serum ferritin concentration measured in blood samples using standard clinical laboratory methods. |
| Transferrin level | From baseline to Day 180. | Serum transferrin concentration measured in blood samples using standard clinical laboratory methods. |
| Transferrin saturation | From baseline to Day 180. | Transferrin saturation percentage calculated from iron metabolism parameters obtained from blood samples. |
| Serum zinc level | From baseline to Day 180. | Serum zinc concentration measured in blood samples using standard clinical laboratory methods. |
| 25-hydroxyvitamin D level | From baseline to Day 180. | Serum 25-hydroxyvitamin D concentration measured in blood samples using standard clinical laboratory methods. |
| Serum folate level | From baseline to Day 180. | Serum folate concentration measured in blood samples using standard clinical laboratory methods. |
| Vitamin B12 level | From baseline to Day 180. | Serum vitamin B12 concentration measured in blood samples using standard clinical laboratory methods. |
| Serum albumin level | From baseline to Day 180. | Serum albumin concentration measured in blood samples using standard clinical laboratory methods. |
| Thyroid-stimulating hormone (TSH) level | From baseline to Day 180. | Serum thyroid-stimulating hormone concentration measured in blood samples using standard clinical laboratory methods. |
| Free thyroxine (free T4) level | From baseline to Day 180. | Serum free thyroxine concentration measured in blood samples using standard clinical laboratory methods. |
| Total testosterone level | From baseline to Day 180. | Serum total testosterone concentration measured in blood samples using standard clinical laboratory methods. |
| Free testosterone level | From baseline to Day 180. | Serum free testosterone concentration measured in blood samples using standard clinical laboratory methods. |
| Dehydroepiandrosterone sulfate (DHEA-S) level | From baseline to Day 180. | Serum dehydroepiandrosterone sulfate concentration measured in blood samples using standard clinical laboratory methods. |
| Sex hormone-binding globulin (SHBG) level | From baseline to Day 180. | Serum sex hormone-binding globulin concentration measured in blood samples using standard clinical laboratory methods. |
| Fasting glucose level | From baseline to Day 180. | Fasting blood glucose concentration measured in blood samples using standard clinical laboratory methods. |
| Glycated hemoglobin (HbA1c) | From baseline to Day 180. | Glycated hemoglobin measured in blood samples using standard clinical laboratory methods. |
| Fasting insulin level | From baseline to Day 180. | Fasting serum insulin concentration measured in blood samples using standard clinical laboratory methods. |
| HOMA-IR | From baseline to Day 180. | Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) calculated from fasting glucose and fasting insulin values. |
| Total cholesterol level | From baseline to Day 180. | Total cholesterol concentration measured in blood samples using standard clinical laboratory methods. |
| HDL cholesterol level | From baseline to Day 180. | HDL cholesterol concentration measured in blood samples using standard clinical laboratory methods. |
| LDL cholesterol level | From baseline to Day 180. | LDL cholesterol concentration measured in blood samples using standard clinical laboratory methods. |
| Triglyceride level | From baseline to Day 180. | Serum triglyceride concentration measured in blood samples using standard clinical laboratory methods. |
| Aspartate aminotransferase (AST) level | From baseline to Day 180. | AST concentration measured in blood samples using standard clinical laboratory methods. |
| Alanine aminotransferase (ALT) level | From baseline to Day 180. | ALT concentration measured in blood samples using standard clinical laboratory methods. |
| Gamma-glutamyl transferase (GGT) level | From baseline to Day 180. | GGT concentration measured in blood samples using standard clinical laboratory methods. |
| Blood urea level | From baseline to Day 180. | Blood urea concentration measured in blood samples using standard clinical laboratory methods. |
| Serum creatinine level | From baseline to Day 180. | Serum creatinine concentration measured in blood samples using standard clinical laboratory methods. |
Countries
Spain
Outcome results
None listed