Clinical Evaluation of a Nutraceutical Supplement (Olistic Women) for Hair Growth and Hair Loss i… (NCT07111312) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of a Nutraceutical Supplement (Olistic Women) for Hair Growth and Hair Loss in Human Volunteers
Spain106 participantsStarted 2023-10-10
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Increase in hair density
Timeframe: From enrollment to the end of treatment at 180 days.