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.
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.
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.
Olistic Research Labs S.L.
Lead sponsor
Grupo Dermatologico Y Estetico Pedro Jaen S.A.
Collaborator