Actively Recruiting
Clinical Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers Versus Placebo
Led by Olistic Research Labs S.L. · Updated on 2025-12-30
100
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to evaluate the efficacy and safety of Olistic Next Women, a nutraceutical supplement, in women experiencing beginning of FPHL. This 6-month, double-blind, placebo-controlled, 1:1 randomized clinical trial investigates whether daily supplementation with Olistic Next Women leads to significant improvements in hair parameters compared to placebo. The study also monitors the tolerability and safety of the product throughout the intervention.
CONDITIONS
Official Title
Clinical Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers Versus Placebo
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 50 to 65 years
- Volunteers with initial female pattern hair loss confirmed by dermatologist assessment
- Commitment not to use systemic, topical, or oral hair-effecting products during the study
- No changes in daily cosmetic or dietary routines throughout the study
- Agreement to follow all protocol requirements
- Availability to attend all study visits
You will not qualify if you...
- Allergy or sensitivity to the product components or similar products
- Previous dermatological treatments for hair loss or hair transplant
- Scalp diseases such as cicatricial alopecia, alopecia areata, folliculitis decalvans, psoriasis, severe seborrheic dermatitis, eczema, or cancer
- Hair loss caused by medical conditions like hypothyroidism, anemia, or lupus
- Significant skin marks on study areas affecting measurements
- Current use of relevant pharmacological or hormonal treatments (e.g., valproic acid, carbamazepine, phenytoin)
- Thyroid disorders (hyper- or hypothyroidism)
- Participation in similar studies or use of anti-hair loss products within the last 3 months
- Treatment with anticoagulants, antifungals, anxiolytics, amphetamines, retinoids, iron, antithyroid drugs, anticonvulsants, beta blockers, ACE inhibitors, minoxidil, finasteride, or similar
- Hormonal treatments started within 6 months before the study
- Chronic drug use started less than 6 months before the study
- Modified diets like low-calorie or Atkins diet
- Pregnant, postpartum (within 6 months), breastfeeding, or planning pregnancy
- Systemic diseases such as cardiac or psychiatric conditions or gastrointestinal diseases
- Serious illnesses that may worsen with study participation
- Planned hairstyle changes during the study
- Presence of skin diseases or melanomas
- Expected changes in routine or lifestyle during the study
- Previous minoxidil use less than 6 months prior, or antiandrogens less than 12 months prior
- Additional exclusion criteria as determined by the study team
AI-Screening
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Trial Site Locations
Total: 1 location
1
Bionos Biotech Clínica
Valencia, Spain
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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