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Tests treatment safety and results for Telogen Effluvium
Official title Efficacy and Safety of a Drinkable Nutraceutical for Hair Loss in Patients Using GLP-1/GIP Receptor Agonists
ClinicalTrials.gov ID: NCT07484061
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 and older, women only
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- 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.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 35 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.