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New treatment option for Early Female Pattern Hair Loss (FPHL)
Official title Clinical Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers
ClinicalTrials.gov ID: NCT07347145
What this study is testing
- What it's testing
- 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 female pattern hair loss (FPHL).This 6-month, double-blind, placebo-controlled, 2:1 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 65, women only
You may be able to join if
- Female people with female pattern hair loss
- 45-65 years
- Signed informed consent
- The study participant is in good general condition for her age and does not currently have any active diseases that, in the opinion of the...
You likely can't join if
- Known or documented intolerance/allergy to any of the ingredients of the study product
- Chronic wounds, erosions, pre-existing infected skin or inflammation in the study area
- Suspected non-compliance
- Late onset acne
- Hirsutism
- Any systemic immunosuppressant given within the 12 months prior to the study (e.g. systemic Prednisolone in high doses, Azathioprine, Metothrexate...
See the full eligibility criteria
- Female people with female pattern hair loss
- 45-65 years
- Signed informed consent
- The study participant is in good general condition for her age and does not currently have any active diseases that, in the opinion of the investigator, justify exclusion from the study.
- Known or documented intolerance/allergy to any of the ingredients of the study product
- Chronic wounds, erosions, pre-existing infected skin or inflammation in the study area
- Suspected non-compliance
- Late onset acne
- Hirsutism
- Any systemic immunosuppressant given within the 12 months prior to the study (e.g. systemic Prednisolone in high doses, Azathioprine, Metothrexate etc.)
- Locally (in the study area) applied products/medicaments which in the opinion of the investigator could lead to an influence of the study results (e.g. topical minoxidil, caffeine etc.)
- Systemically administered products and medicaments which in the opinion of the investigator could lead to an influence of the study results (e.g. hormone-influencing medicaments, medicaments which frequently lead to...
- people receiving stable hormone replacement therapy (HRT) for \<6 months prior to screening will be excluded.
- people who follow an exclusively or mainly vegan diet
- Known or documented Gluten intolerance
- Lactose intolerance
- Hyperthyroidism
- people with hypothyroidism with non-stable thyroid-stimulating hormone (TSH) levels will be excluded.
- Other diseases of the scalp which in the opinion of the investigator could lead to an influence of the study results (e.g. Lichen planus, Psoriasis capitis, scarring alopecia etc.)
- Participation in a clinical trial/study
- Participation in a clinical trial/study within the last 30 days
- Deviations from the norm in the following laboratory values in the blood test of the screening visit: zinc, ferritin, selenium, folic acid, vitamin B12, TSH, and CRP. (Only at Baseline)
The study team makes the final eligibility decision.
Where it's taking place
- Wuppertal, Barmen, Germany
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, 45 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuppertal, Barmen, Germany. 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.