Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07484061
Eligibility Criteria:
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 exclusion criteria to be specified by the sponsor.
* Any condition that, in the investigator's opinion, makes participation in the study inappropriate.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Study:
NCT07484061
Study Brief:
Protocol Section:
NCT07484061