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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olistic Next Women | Active Comparator |
| |
| Placebo Arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, amino acids, and other bioactive compounds, formulated to support hair growth and scalp health in women. | Dietary Supplement | Drinkable multifactorial food supplement in liquid form, administered once daily in a 25 mL single-dose vial, for a duration of 180 days. The formulation contains a combination of vitamins, minerals, plant extracts, amino acids, and other bioactive compounds designed to support hair growth and scalp health in women. |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in hair density | From phototrichogram on the Sagittal midline area of the scalp. | From enrollment to the end of treatment at 180 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hair shedding | Hair shedding will be assessed by collecting shed hairs during a standardized washing and combing procedure. | From enrollment to the end of treatment at 180 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CentroDerm | Recruiting | Wuppertal | Barmen | 42287 | Germany |
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|
| Placebo control | Other | Drinkable formulation consisting of an excipient formulation designed to mimic the organoleptic properties of the active product, reproducing its color and texture while achieving a highly similar taste profile. |
|
| ID | Term |
|---|---|
| D008903 | Minerals |
| D010936 | Plant Extracts |
| D000596 | Amino Acids |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004364 | Pharmaceutical Preparations |
| D000602 | Amino Acids, Peptides, and Proteins |
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