Telogen Effluvium
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTDrinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.
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.
OTHERPlacebo control
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.
Sponsors
Olistic Research Labs S.L.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-40 years * Sex: female * Telogen effluvium diagnosis with hair loss \> 100 hairs, confirmed using validated modified wash test * Otherwise, healthy volunteers * Refraining from systemic, topical, oral products with similar effects to the active product * Signed informed consent * Maintenance of daily cosmetic and dietary routine * Availability to attend all visits * Compliance with all protocol requirements
Exclusion criteria
* Previous use of active product * Participation in similar studies or usage of anti-hair loss products within the last 3 months * History of dermatological treatment (e.g. mesotherapy) and/or hair transplant * Skin or scalp diseases (e.g. psoriasis, dermatitis, alopecias) * Alopecia secondary to medical diseases (e.g. hypothyroidism, anemia) * Ongoing treatment for or diagnosis of systemic disease * Hormonal treatment (oral or topical contraceptives) within 6 months prior to study start * Known allergy or intolerance, including to any of the ingredients of the active product * Pregnancy, post-partum (6 months) or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase in hair density | From enrollment to the end of treatment at 180 days. | From phototrichogram on the temporoparietal area of the scalp. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Anagen-to-Catagen/Telogen ratio | From enrollment to the end of treatment at 180 days. | From phototrichogram on the temporoparietal area of the scalp. |
Countries
Spain
Outcome results
None listed