There are two types of hair growth solutions which are frequently confused: hair loss treatments and supplementary hair growth products
Whilst hair loss treatments
are medications, MHRA-licensed and FDA-approved for the treatment of Male Pattern Baldness
and Female Pattern Hair Loss
, supplementary products are non-pharmaceutical. These can range from low-level laser therapy (LLLT) devices to food supplements targeted towards supporting normal hair growth.
Now a new product entering its first clinical trial stage hopes to bridge the gap between Male Pattern Hair Loss Treatment and food supplements such as Hair Vitalics for Men
Nutraceutical hair supplement for men
A new clinical trial registration, submitted by DeNova Research, has appeared on the clinicaltrials.gov database entitled: Oral Nutraceutical Supplement With Standardized Botanicals in Males With Self-Perceived Thinning Hair and Loss.
It is looking to compare changes in hair count, shaft thickness and hair density in men using a placebo capsule with those taking an oral nutraceutical supplement comprising 'standardized botanicals'. In each instance four oral capsules are to be taken daily with a meal.
The trial will review changes to each participant's hair at the 90, 180, 270 and 360 day points.
The researchers are enrolling 74 men between 21 and 45 years of age (inclusive) who have self-reported hair loss
or thinning hair which has been present for at least three months.
Those with clinically-confirmed Male Pattern Baldness - also known as androgenetic alopecia - may be included if their levels of hairloss are consistent with 'frontal and vertex patterns II, IIIv or IV' using the Norwood-Hamilton Scale
Those with forms of hairloss other than Male Pattern Baldness - including Alopecia Areata
and Cicatricial Alopecia
- or skin conditions including psoriasis and eczema, are excluded from the study. Participants must also agree not to use any medicated shampoo, either prescription or over-the-counter formulations, including dandruff shampoos
, for the duration of the study. Any men taking medications
known to cause hair loss as a side effect, or affect hair growth in any other way, are also ineligible.
Men using either of the clinically-proven male pattern hair loss treatments
- finasteride 1mg or minoxidil - or LLLT devices
for hair growth are disqualified, as are those who have had a hair transplant
, whilst smokers
who smoke 20 cigarettes per day or more are also ineligible to take part in this trial.
What does nutraceutical mean?
'Nutraceutical' is the blend word formed from 'nutritional' and 'pharmaceutical'. According to the Royal Pharmaceutical Society publication the Pharmaceutical Journal, 'The term “nutraceutical” was coined in 1989 by Stephen De Felice, founder and chairman of the Foundation for Innovation in Medicine, an American organization which encourages medical health research.1?3 He defined a nutraceutical as a “food, or parts of a food, that provide medical or health benefits, including the prevention and treatment of disease”.'
Essentially nutraceuticals are derived nutrients which have a higher benefit that when those nutrients are taken straight from their food source.
The DeNova documentation for this research states that the study is not related to an FDA-regulated drug product.
Currently nutraceuticals, being still a fairly new concept, are in something of a grey area when it comes to regulation and the term nutraceutical currently has no legal status. In Europe nutraceuticals are subject to EU food laws - and sometimes additional 'novel food' requirements; in the USA, the FDA does not currently approve nutraceutical products but monitors them as food supplements under the Dietary Supplement, Health and Education Act (DSHEA) of 1994.