Efficacy and Safety Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin … (NCT07300228) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers
Spain39 participantsStarted 2024-09-16
Plain-language summary
The purpose of this clinical trial is to evaluate the efficacy and safety of Olistic Next Women, a nutraceutical supplement, in women diagnosed with early FPHL.This 6-month, open-label, interventional clinical trial investigates whether daily supplementation with Olistic Next Women leads to significant improvements in hair parameters. The study also monitors the tolerability and safety of the product throughout the intervention.
Who can participate
Age range50 Years – 65 Years
SexFEMALE
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Inclusion Criteria:
* Women aged 50-65.
* Volunteers with initial FPHL. (Images will be sent to a dermatologist for assessment).
* Commitment not to use systemic, topical, or oral products with an effect similar to that of the product to be evaluated throughout the study period.
* Do not change the daily routine regarding the use of cosmetic products and eating habits.
* Commitment to comply with all protocol requirements specified in the subject information sheet.
* Availability to comply with all study visits.
Exclusion Criteria:
* Women who have undergone dermatological treatment for hair loss (PRPs, mesotherapy, etc.) or hair transplant.
* Scalp diseases: cicatricial alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate severe seborrheic dermatitis, eczema, cancer, etc.
* Women who present alopecia because of a medical illness (hypothyroidism, anemia, lupus, etc.).
* Relevant cutaneous marks in the experimental areas, which could interfere with the measurements (scars, sunburns, etc.).
* In-use relevant pharmacological or hormonal treatment (eg. valproic acid, carbamazepine, phenytoin).
* Women with thyroid alteration (hyper- or hypothyroidism)
* Women who have previously participated in similar studies or who have used anti-hair loss products in the last 3 months.
* Women who are being treated with anticoagulants, antifungals, anxiolytics, amphetamines, retinoids, iron, antithyroid, anticonvulsants, beta blockers and/or ACE inhibitors, minoxidil, fina…
What they're measuring
1
Increase in hair density
Timeframe: From enrollment to the end of treatment at 180 days.