Clinical Evaluation of a Nutraceutical Supplement for Hair Growth, Hair Loss and Skin Improvement in Human Volunteers Versus Placebo

Olistic Research Labs S.L.

Status: Enrolling

Conditions: Early Female Pattern Hair Loss (FPHL)

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

NCT07111299

CT-ON-03

Details and patient eligibility

About

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 FPHL.

This 6-month, double-blind, placebo-controlled, 1:1 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 50 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 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