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Hair loss is a multifactorial and complex condition influenced by factors such as hormonal changes, vitamin and mineral deficiencies, genetic predisposition, oxidative stress, aging, inflammation, and psychological stress. This 6-month randomized, double-blind, placebo-controlled study aimed to evaluate the efficacy and safety of a drinkable nutraceutical formulated with natural, high-quality, patented, and standardized ingredients designed to support hair health through multiple biological pathways. A total of 106 premenopausal women aged 18 to 40 years and diagnosed with telogen effluvium were randomized to receive either the nutraceutical (n = 53) or placebo (n = 53). The primary endpoint was the increase in hair density from baseline versus placebo. The secondary endpoint was the change in the anagen-to-catagen/telogen (A:C/T) ratio. These parameters were assessed using phototrichoscopy and phototrichogram via TrichoScan®. The study was approved by an ethics committee and conducted by two independent board-certified dermatologists at two study sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Product Arm | Active Comparator |
| |
| Placebo Arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, 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 temporoparietal area of the scalp. | From enrollment to the end of treatment at 180 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Anagen-to-Catagen/Telogen ratio | From phototrichogram on the temporoparietal area of the scalp. | 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 |
|---|---|---|---|---|---|---|
| Zurko-CTC | Barcelona | Spain | ||||
| ClÃnica AB Derma |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41288927 | Derived | Bernardez C, Podlipnik S, Westgate GE, Paus R, Zamfir L, Grohmann D, Saez Moya M. Efficacy and Safety of a Drinkable Nutraceutical in Premenopausal Women with Telogen Effluvium: A 6-Month, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study. Dermatol Ther (Heidelb). 2026 Jan;16(1):521-534. doi: 10.1007/s13555-025-01585-x. Epub 2025 Nov 25. |
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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. |
|
| Madrid |
| Spain |
| ID | Term |
|---|---|
| D008903 | Minerals |
| D010936 | Plant Extracts |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004364 | Pharmaceutical Preparations |
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