“Cold” X5 Hairlaser™ used to treat male androgenic alopecia and hair growth: an uncontrolled pilot study

BMC Research Notes, Dec 2014

Background Various trials have been conducted on the management and treatment of androgenic alopecia (AGA) or male pattern hair loss using a variety of laser and light sources. Methods For this feasibility study, the population was composed of males between the ages of 20 and 60 years who have been experiencing active hair loss within the last 12 months and the diagnosis of AGA. They also had a Norwood-Hamilton classification of 3, 3A, 3 V, 4, 4A, or 5 for the hair thinning patterns and skin type I, II, III, or IV on the Fitzpatrick skin type scale. This two-arm randomized, parallel group study design employed stratifying randomization to balance treatment assignment within three investigational centers with at least 2 subjects enrolled in each Fitzpatrick skin type. Results A statistically significant positive trend in hair growth was observed from this pilot study, to evaluate the efficacy of the novel cold X5 hairlaser device for treating male androgenic alopecia. From the repeated measures analysis of variance, difference in mean hair counts over time was statistically significant (F = 7.70; p-value < 0.0001). Subsequent, linear regression of mean hair counts at each time point was performed, and post-hoc analysis found an increasing trend of hair growth over time that was statistically significant (p-value < 0.0001) with the estimated slope of 1.406. Increased hair counts from the baseline to the end of the 26-week period were found to be strongly significant (p-value = 0.0003). Conclusion Albeit, sham device failure and resultant missing data from the control group, the positive trend hair growth, was observed due to the chronic use of X5hairlaser device. This positive benefit while in full agreement with other low laser hair devices requires intensive further investigation. Trial registration NCT02067260

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“Cold” X5 Hairlaser™ used to treat male androgenic alopecia and hair growth: an uncontrolled pilot study

BMC Research Notes Kenneth Blum 0 2 3 David Han 1 Margaret A Madigan 0 Raquel Lohmann 3 Eric R Braverman 2 3 0 Department of Nutrigenomics, IGENE, LLC , Austin, TX , USA 1 Department of Biostatistics, University of Texas at San Antonio , San Antonio, TX , USA 2 Department of Psychiatry and McKnight Brain Institute, University of Florida, College of Medicine , Gainesville, FL , USA 3 Department of Clinical Neurology , Path Foundation NY, New York, NY , USA et al. - “Cold” X5 Hairlaser™ androgenic alopecia an uncontrolled pilot used to and hair study treat male growth: Blum Blum et al. BMC Research Notes 2014, 7:103 http://www.biomedcentral.com/1756-0500/7/103 “Cold” X5 Hairlaser™ used to treat male androgenic alopecia and hair growth: an uncontrolled pilot study Background Epidemiology: defining androgenic alopecia Androgenic alopecia (also known as androgenetic alopecia or alopecia androgenetica) is the most common cause of hair loss, and thinning in humans [ 1 ]. Androgenic alopecia (AGA) affects an estimated 50 million men and 30 million women in the United States. Genetic predisposition to hereditary hair loss can be inherited from either side of a * Correspondence: 1Department of Psychiatry and McKnight Brain Institute, University of Florida, College of Medicine, Gainesville, FL, USA 3Department of Nutrigenomics, IGENE, LLC, Austin, TX, USA Full list of author information is available at the end of the article person’s family or both parents. It is found in men and women of all races and ethnicities. By age 40, forty percent of women and nearly forty percent of men have visible symptoms of hereditary hair loss. By age 50, fifty percent of both genders show signs of the condition. Hair loss is a common and distressing condition. Americans are expected to spend about one billion dollars annually for treatments to combat and cover up hair loss [ 2,3 ]. It is well known that both Finasteride® and Minoxidil® are effective treatment methods, but patients who exhibit a poor response to these methods have no additional adequate treatment modalities [ 4,5 ]. In this regard, Kim et al. reported that after 24 weeks of treatment, a low-level light therapy LLLT group showed significantly greater hair density than the sham device group [6]. In addition Leavitt et al. [ 7 ] reported that the HairMax LaserComb treatment group showed a significantly greater increase in mean terminal hair density than subjects in the sham device group (p < 0.0001). Moreover, significant improvements in overall hair regrowth were demonstrated in terms of patients' subjective assessment (p < 0.015) at 26 weeks when compared to baseline. Variants appear in both men and women. However, AGA is also commonly known as male pattern baldness. In males’ classic pattern baldness, hair is lost in a welldefined pattern, beginning above both temples. Hair also thins at the crown of the head. Often a rim of hair around the sides and rear of the head is left. This pattern is dubbed "Hippocratic balding" and may rarely progress to complete baldness. Women do not suffer classic male pattern baldness, instead the hair becomes thinner around the whole scalp, and the hairline does not recede. This is dubbed "female pattern baldness" and may occur in males. This variety of AGA in women rarely leads to total baldness [ 1,8 ]. Androgenic alopecia More than 95 percent of hair loss in men is caused by AGA. Male pattern baldness is considered a genetic condition, inherited from either the mother or the father's side of the family. However, male pattern baldness also requires the presence of the male hormone testosterone. Genetics cause hair follicles to become sensitive to dihydrotestosterone (DHT), a byproduct of testosterone [ 9 ]. The follicles begin to grow smaller, have a shorter life span and eventually fall out altogether or leave behind fuzz. Various genetic (and possibly environmental-epigenetic) factors apparently play a role in AGA. Although researchers have long studied the factors that may contribute to this condition, many remain unknown. Recently the existing theories have been challenged on the ground that while the androgens in question are responsible for hair growth on the face and all over the body of men, hair loss only occurs at the top of the scalp. For example, it has been suggested that AGA is a consequence of the anabolic effect of androgens such as hormonal changes leading to structural changes in skin and scalp which in turn cause hair loss [ 10 ]. It should be noted, however, that there are as of yet no experiments testing this hypothesis. The genetic and hormonal component of male pattern baldness Much research concerns the genetic component of male pattern baldness, or AGA research indicates that susceptibility to premature male pattern baldness is largely X –linked, which means it is linked to genes on an X-chromosome. Other genes that are not sex linked are also involved. Men whose fathers had experie (...truncated)


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Kenneth Blum, David Han, Margaret A Madigan, Raquel Lohmann, Eric R Braverman. “Cold” X5 Hairlaser™ used to treat male androgenic alopecia and hair growth: an uncontrolled pilot study, BMC Research Notes, 2014, pp. 103, Volume 7, Issue 1, DOI: 10.1186/1756-0500-7-103