Olistic Next Women daily supplement for early female hair thinning

Clinical Evaluation of Hair Loss, Hair Growth, and Skin Improvement in Human Volunteers Following a Double-blind, Placebo-controlled, 1:1 Randomized Trial of 'Olistic Next Women'

Over 6 months this will test whether taking one daily Olistic Next Women drinkable supplement helps women aged 50–65 with early female pattern hair loss get thicker, healthier hair compared with a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 50 Years to 65 Years
• Sex: Female
• Sponsor: Olistic Research Labs S.L. (Industry-sponsored)
• Locations: 1 site (Valencia)
• Trial ID: NCT07111299 on ClinicalTrials.gov

What this trial studies

This is a 6-month, double-blind, randomized (1:1) placebo-controlled trial comparing a drinkable multifactorial nutraceutical to placebo in women with early female pattern hair loss. Participants and study staff are blinded to assignment, and the active product contains vitamins, minerals, plant extracts, and other bioactive compounds thought to support hair and scalp health. Hair parameters will be measured and images reviewed by a dermatologist, and safety and tolerability will be monitored throughout the intervention. Participants agree to avoid other systemic or topical hair-loss treatments and to maintain usual cosmetic and dietary routines during the study period.

Who should consider this trial

Good fit: Women aged 50–65 with early-stage female pattern hair loss who can attend study visits, avoid other hair-loss treatments during the trial, and have no contraindicating scalp disease are the intended participants.

Not a fit: Women with scarring or advanced alopecia, hair loss driven by untreated medical conditions (for example hypothyroidism), recent hair transplant or dermatologic hair procedures, or allergies to product components are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the supplement could provide a safe, non-prescription option to reduce hair thinning and improve hair thickness and scalp health in women with early FPHL.

How similar studies have performed: Some small trials and ingredient-specific research have shown modest hair-health benefits from certain vitamins and botanical extracts, but high-quality randomized evidence for combined nutraceutical drinks in FPHL is limited.

Eligibility criteria

Inclusion Criteria:

* Women aged 50-65.
* Volunteers with initial FPHL. (Images will be sent to a dermatologist for assessment).
* Commitment not to use systemic, topical, or oral products with an effect similar to that of the product to be evaluated throughout the study period.
* Do not change the daily routine regarding the use of cosmetic products and eating habits.
* Commitment to comply with all protocol requirements specified in the subject information sheet.
* Availability to comply with all study visits.

Exclusion Criteria:

* Allergy or reactivity to some of the components of the product, or a product with similar category than tested one.
* Women who have undergone dermatological treatment for hair loss (PRPs, mesotherapy, etc.) or hair transplant.
* Scalp diseases: cicatricial alopecia, alopecia areata, folliculitis decalvans, psoriasis, moderate severe seborrheic dermatitis, eczema, cancer, etc.
* Women who present alopecia because of a medical illness (hypothyroidism, anemia, lupus, etc.).
* Relevant cutaneous marks in the experimental areas, which could interfere with the measurements (scars, sunburns, etc.).
* In-use relevant pharmacological or hormonal treatment (eg. valproic acid, carbamazepine, phenytoin).
* Women with thyroid alteration (hyper- or hypothyroidism)
* Women who have previously participated in similar studies or who have used anti-hair loss products in the last 3 months.
* Women who are being treated with anticoagulants, antifungals, anxiolytics, amphetamines, retinoids, iron, antithyroid, anticonvulsants, beta blockers and/or ACE inhibitors, minoxidil, finasteride, etc.
* Women who started hormonal treatment (oral or topical contraceptives) in the 6 months prior to the start of the study.
* Women who started taking any drug chronically less than 6 months before the start of the study (they should have a stable situation with the medication over 6 months).
* Modification of the usual diet: low-calorie diet, Atkins diet, etc.
* Pregnant, postpartum (6 months) or breastfeeding women, or who intend to get pregnant during the duration of the study.
* Evidence of systemic diseases (e.g. cardiac disease, psychiatric disease, etc.) or gastrointestinal diseases.
* Serious conditions or illnesses that, in the opinion of the researcher, may be aggravated by participation in the study or that put the development of the study at risk.
* Planned hairstyle changes throughout the study
* Presence of skin diseases or melanomas.
* Forecast of change of routine or relevant way of life, during the period of study.
* Other exclusion criteria to be added by the customer.
* Women who have gone dermatological treatment, that they have introduced minoxidil (oral or topical) at least 6 months prior, and antiandrogens (e.g. finasteride) at least 12 months before the start of the study.

Where this trial is running

Valencia

• Bionos Biotech Clínica — Valencia, Spain (Recruiting)

Conditions Early Female Pattern Hair Loss