Replenology trial results a boost for female hair loss
18 Nov 2021 --- A research study into the patent-pending botanical Replenology hair system from Arbor Life Labs has published the results of its pivotal clinical trial on hair loss in women in The Lancet's journal, EClinicalMedicine. The paper has also featured in The Lancet's Specialty Collection on Regenerative Medicine. Replenology is designed to provide a natural way to promote healthy hair growth, prevent hair loss and activate dormant hair follicles.
Detailing what inspired Arbor to explore the female hair loss market and develop a system to tackle this problem, CEO Peter Feldman says: “Arbor Life Labs committed themselves to create an effective solution for alopecia that is safe to use, clean label, gluten free, GMO free and meets the needs of all lifestyles, including athletes and various professionals.”
Click to EnlargeSo, how common is hair loss among females? “Hair thinning in women can begin between the ages of 12 and 40 and it becomes noticeable in about half of the female population by their fifth decade,” explains Feldman.
“Hair loss has been related to hormonal disturbances, chronic medical conditions, use of certain drugs, topical scalp treatments and chemo and radiotherapy,” he adds. “It has also been linked to sudden weight loss, low protein intake, stress and pollution. Miscellaneous hair disorders and alopecia have also been associated with deficiencies in minerals such as copper, iron, selenium and zinc, as well as of vitamins such as niacin and vitamin D.”
Arbor had an understanding of the concerns around hair loss prior to engaging in its recent research. Although hair loss is a sign of normal aging, Arbor recognized its association with impaired quality of life, metabolic syndrome and increased mortality. The company also noted that most pharmaceuticals or other natural formulations use high-dose compounds targeting few biological pathways, which can lead to limited effectiveness and adverse effects. Similarly, it recognized that the only Food and Drug Administration (FDA) approved treatment for hair loss in women is effective in only 13-40% of women.
A scientific and medical literature review of hair follicle biology, the compounds influencing hair regrowth and previous clinical trials showed that hair follicle regeneration and maintenance is associated with the expression of more than 1,000 genes and is dependent on hair follicle stem cell activation. It is also influenced by a complex, rhythmic behavior of multiple molecular pathways that often have opposing influences. “Therefore, a single cause of hair loss is unlikely, and scientific and medical experts have proposed that the next generation of hair loss therapies should aim to address multiple targets by oral, topical or a combination delivery regimen,” says Feldman.
The Replenology hair system
Arbor researched and screened the biological mechanisms of many botanicals, vitamins and minerals relevant to hair follicle health. From this research came the Replenology hair system (ALRV5XR) for oral or topical use, with the aim of modulating at least 21 of the accepted molecular pathways involved in healthy hair follicles and hair growth. It’s patent-pending system relates to its formulation and the use of specific botanicals to activate hair stem cells to grow hair and repair skin.
The formulation has been developed to support seven categories of hair follicle health including growth factors, circulation, anti-androgens, follicle protection, hair stem cell stimulation, immune regulation and nutrition. The hair care system uses active ingredients that have all been well documented in scientific literature as being associated with aspects of healthy hair growth.
Click to EnlargeSource: Arbor Life LabsCommenting on the impact Arbor hopes to have on the female hair loss market, Feldman notes: ”Replenology is the only product to date that has used specific nutrients to target 21 biological pathways in the hair follicle that support normal hair growth. The rigor and success of the clinical trial, as published by a premium peer-reviewed journal, has set a new standard for women experiencing hair loss. These results also simplify the marketing message, since we don’t have to invent phrases and claims that make the product sound better than it really is.”
There are two types of hair on the scalp - terminal and vellus hair. The primary objectives of the 24-week trial were to evaluate the safety and efficacy of Replenology in terminal hair regrowth in women with Androgenetic Alopecia or Telogen Effluvium. “Terminal hair is the thicker, pigmented and longer hair of the scalp, which contributes to a woman's unique identity and beauty,” says Feldman. “Vellus hair is the thin, short and often non-pigmented hair. It contributes very little to a woman’s appearance.”
A typical healthy scalp has about 85% terminal hair and 15% vellus hair. As hair thinning advances, terminal hair miniaturizes into vellus hair by becoming progressively thinner, shorter, and shedding more frequently. After these miniaturized hairs shed, the normal 100- day dormancy period before hair starts to regrow can be extended by months or years. When vellus hair exceeds 20% of hair in any area of the scalp, thinning becomes visibly noticeable.
The clinical trial measured terminal hair density by phototrichograms - a non-invasive, high definition, microscopic digital image of an area on the scalp, with hair cut to less than 1mm in length and dyed for uniform visibility and contrast against the scalp. Measurements were taken at baseline, 12 weeks and 24 weeks. A computerized image analysis system measured details about each hair. The data was then analyzed by a biostatistician to determine changes in terminal and vellus hair densities, with the differences between the Replenology and placebo groups scrutinized. Safety was evaluated by over 80 measurements at each visit, including blood and urine laboratory tests, a physical examination and any reports from the study subjects.
Results and findings
A total of 46 subjects comprising 23 Replenology (ALRV5XR) and 23 placebo were enrolled in the trial in San Francisco, California. The group of participants experienced a range of conditions including female patterned hair loss, hair thinning or diffuse hair loss. At 24 weeks, the change in terminal hair density, when compared to placebo, improved by 30.1 terminal hairs per cm2 (p=0.0002), and the relative density increased by 19.7% (p=0.0016). Efficacy increased 133% from week 12 to 24. Efficacy outcomes were similar in the Androgenetic Alopecia and Telogen Effluvium subjects, with 67% of the Replenology group responding by regrowing 40 terminal hairs or more per cm2.
Click to EnlargeThe results have fared well against previous trials. Source: Arbor Life LabsThe efficacy of total hair density - the number by which Replenology improved over placebo - was 33.9 hairs per cm2 (p=0.0001) and 18.6% (p=0.0004). The result saw a fourfold improvement in hair growth and response rates in just 24 weeks when compared with clinical trials of currently available hair loss products. The researchers also found hair regrowth accelerated during the trial.
The average scalp has about 700cm2 of hair coverage with 100-150,000 hairs. If the change in density was applicable to the whole scalp, this means that the average woman could increase scalp hair density by about 21,000 terminal hairs over 24 weeks. Hypothetically, if the regrowth rate at week 24 is maintained, 92% of women responding to Replenology may gain more than 28,000 new terminal hairs, and 58% more than 35,000 new terminal hairs.
“The results of this trial showed a fourfold increase of published trials with different products; that is, women saw more hair regrow in a shorter time than comparable studies over a longer period,” Feldman details.
“These results suggest that for women of all ages there is the potential to maintain their existing thicker/terminal hair and reactivate dormant hair follicles to grow even more,” says Feldman. Hair grows approximately 1cm per month and seeing new hair growth at the scalp level can take many months to become visibly noticeable. “However, the stress associated with experiencing daily hair fall can be relieved within as little as two to three weeks (on average) while the new growth will be nourished and stimulated,” adds Feldman.
The publication concluded that a woman may restore her normal hair density with extended use of the Replenology hair system, leading Feldman to say: "The clinical significance of this trial's results is a major milestone for the company. Since 1995, scientists have said that there is no single molecule, either orally or topically delivered, that can solve the problem of hair loss. Likewise it has been stated that there is no single botanical that can target all aspects of hair follicle health. The Replenology formulation, however, is a nutrient combination that supports the requirements of healthy functioning hair follicles.”
By Natasha Spencer-Jolliffe, BPC Insights Senior Journalist
