NCT07300228CompletedNot Applicable
Clinical Evaluation of Hair and Skin Health in Human Volunteers, Following a 6-month Open-label Interventional Study of 'Olistic Next Women'
Olistic Research Labs S.L.1 site in 1 country39 target enrollmentStarted: September 16, 2024Last updated:
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Increase in hair density
Study Overview
Brief Summary
The purpose of this clinical trial is to evaluate the efficacy and safety of Olistic Next Women, a nutraceutical supplement, in women diagnosed with early FPHL.This 6-month, open-label, interventional clinical trial investigates whether daily supplementation with Olistic Next Women leads to significant improvements in hair parameters. The study also monitors the tolerability and safety of the product throughout the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women aged 50-
- •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
- •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.
- •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 investigator.
- •Allergy or reactivity to some of the components of the product, or a product with similar category than tested one.
- •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
Arms & Interventions
Active Product Arm
Experimental
Intervention: Drinkable multifactorial food supplement containing vitamins, minerals, amino acids, plant extracts, and other bioactive compounds, formulated to support hair growth and scalp health in women +50. (Dietary Supplement)
Outcomes
Primary Outcomes
Increase in hair density
Time Frame: From enrollment to the end of treatment at 180 days.
From phototrichogram on the mid interparietal area of the scalp.
Secondary Outcomes
- Change in hair shedding(From enrollment to the end of treatment at 180 days.)
Investigators
Study Sites (1)
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