Clinical Evaluation of a Nutraceutical Supplement (Olistic Women) for Hair Growth and Hair Loss in Human Volunteers

Olistic Research Labs S.L.

Status: Completed

Conditions: Telogen Effluvium

Treatments: Dietary Supplement: Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.; Other: Placebo control

Study type: Interventional

Funder types: Industry

Identifiers

NCT07111312

CT-OW-02

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

106 participants in 2 patient groups, including a placebo group

Active Product Arm

Active Comparator group

Treatment:

Dietary Supplement: Drinkable multifactorial food supplement containing vitamins, minerals, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women.

Placebo Arm

Placebo Comparator group

Treatment:

Other: Placebo control