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

BMC Research Notes

Eric R Braverman²  Raquel Lohmann²  Margaret A Madigan¹  David Han³  Kenneth Blum² 

[1] Department of Nutrigenomics, IGENE, LLC, Austin, TX, USA;Department of Clinical Neurology, Path Foundation NY, New York, NY, USA;Department of Biostatistics, University of Texas at San Antonio, San Antonio, TX, USA

关键词: Linear regression;    Monochromatic light;    Distributed laser light;    Androgenic alopecia;   

Others  :  1134423
DOI  :  10.1186/1756-0500-7-103

 received in 2013-01-26, accepted in 2014-02-10,  发布年份 2014

【 摘 要 】

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

【 授权许可】

   
2014 Blum et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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【 参考文献 】

• [1]Soni VK: Androgenic alopecia: a counterproductive outcome of the anabolic effect of androgens. Med Hypotheses 2009, 73(3):420-426.
• [2]Duverger O, Morasso MI: To grow or not to grow: hair morphogenesis and human genetic hair disorders. Semin Cell Dev Biol 2013. S1084-9521(13)00135-3
• [3]Liang B, Yang C, Zuo X, Li Y, Ding Y, Sheng Y, Zhou F, Cheng H, Zheng X, Chen G, Zhu Z, Zhu J, Fu X, Wang T, Dong Y, Duan D, Tang X, Tang H, Gao J, Sun L, Yang S, Zhang X: Genetic variants at 20p11 confer risk to androgenetic alopeciain the Chinese Han population. PLoS One 2013, 8(8):e71771.
• [4]Chin EY: Androgenetic alopecia (male pattern hair loss) in the United States: what treatments should primary care providers recommend? J Am Assoc Nurs Pract 2013, 25(8):395-401.
• [5]Kaufman KD, Olsen EA, Whiting D, Savin R, DeVillez R, Bergfeld W, Price VH, Van Neste D, Roberts JL, Hordinsky M, Shapiro J, Binkowitz B, Gormley GJ, Finasteride Male Pattern Hair Loss Study Group: Finasteride in the treatment of men with androgenetic alopecia. J Am Acad Dermatol 1998, 39(4 Pt 1):578-589.
• [6]Kim H, Choi JW, Kim JY, Shin JW, Lee SJ, Huh CH: Low-level light therapy for androgenetic alopecia: a 24-week, randomized, double-blind, sham device-controlled multicenter trial. Dermatol Surg 2013, 39(8):1177-1183.
• [7]Leavitt M, Charles G, Heyman E, Michaels D: HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: a randomized, double-blind, sham device-controlled, multicentre trial. Clin Drug Invest 2009, 29(5):283-292.
• [8]Sehgal VN, Srivastava G, Aggarwal AK, Midha R: Hair biology and its comprehensive sequence in female pattern baldness: diagnosis and treatment modalities–Part I. Skinmed 2013, 11(1):39-45.
• [9]Sperling LC, Mezebish DS: Hair diseases. Med Clin North Am 1998, 82(5):1155-1169.
• [10]Gao W, Kim J, Dalton JT: Pharmacokinetics and pharmacodynamics of nonsteroidal androgen receptor ligands. Pharm Res 2006, 23(8):1641-1658.
• [11]Hillmer AM, Hanneken S, Ritzmann S, Becker T, Freudenberg J, Brockschmidt FF, Flaquer A, Freudenberg-Hua Y, Jamra RA, Metzen C, Heyn U, Schweiger N, Betz RC, Blaumeiser B, Hampe J, Schreiber S, Schulze TG, Hennies HC, Schumacher J, Propping P, Ruzicka T, Cichon S, Wienker TF, Kruse R, Nöthen MM: Genetic variation in the human androgen receptor gene is the major determinant of common early-onset androgenetic alopecia. Am J Hum Genet 2005, 77(1):140-148. doi:10.1086/431425
• [12]Cobb JE, Zaloumis SG, Scurrah KJ, Harrap SB, Ellis JA: Evidence for two independent functional variants for androgenetic alopecia around the androgen receptor gene. Exp Dermatol 2010, 19(11):1026-1028. doi:10.1111/j.1600-0625.2010.01132.x
• [13]Levy-Nissenbaum E, Bar-Natan M, Frydman M, Pras E: Confirmation of the association between male pattern baldness and the androgen receptor gene. Eur J Dermatol 2005, 15(5):339-340. PMID 16172040
• [14]Prodi DA, Pirastu N, Maninchedda G, Sassu A, Picciau A, Palmas MA, Mossa A, Persico I, Adamo M, Angius A, Pirastu M: EDA2R is associated with androgenetic alopecia. J Invest Dermatol 2008, 128(9):2268-2270.
• [15]Ellis JA, Scurrah KJ, Cobb JE, Zaloumis SG, Duncan AE, Harrap SB: Baldness and the androgen receptor: the AR polyglycine repeat polymorphism does not confer susceptibility to androgenetic alopecia. Hum Genet 2007, 121(3–4):451-457.
• [16]Hillmer AM, Flaquer A, Hanneken S, Eigelshoven S, Kortüm AK, Brockschmidt FF, Golla A, Metzen C, Thiele H, Kolberg S, Reinartz R, Betz RC, Ruzicka T, Hennies HC, Kruse R, Nöthen MM: Genome-wide scan and fine-mapping linkage study of androgenetic alopecia reveals a locus on chromosome 3q26". Am J Hum Genet 2008, 82(3):737-743. doi:10.1016/j.ajhg.2007.11.014 doi:10.1016%2Fj.ajhg.2007.11.014
• [17]Shimomura Y, Wajid M, Ishii Y, Shapirob Y, Petukhova L, Derek G, Christiano AM: Disruption of P2RY5, an orphan G protein–coupled receptor, underlies autosomal recessive woolly hair. Nat Genet 2008, 40(3):335-339. doi:10.1038/ng.100 doi:10.1038%2Fng.100. PMID 18297072
• [18]Petukhova L, Sousajr E, Martinezmir A, Vitebsky A, Dos Santos LG, Shapiro L, Haynes C, Gordon D, Shimomura Y, Christiano AM: Genome-wide linkage analysis of an autosomal recessive hypotrichosis identifies a novel P2RY5 mutation. Genomics 2008, doi:10.1016/j.ygeno.2008.06.009 doi:10.1016%2Fj.ygeno.2008.06.009. PMID 18692127(5):273-278. doi:10.1016/j.ygeno.2008.06.009 doi:10.1016%2Fj.ygeno.2008.06.009 . PMID 18692127
• [19]Pasternack SM, von Kügelgen I, Aboud KA, Lee YA, Rüschendorf F, Voss K, Hillmer AM, Molderings GJ, Franz T, Ramirez A, Nürnberg P, Nöthen MM, Betz RC: G protein-coupled receptor P2Y5 and its ligand LPA are involved in maintenance of human hair growth. Nat Genet 2008, 40(3):329-334.
• [20]Stárka L, Cermáková I, Dusková M, Hill M, Dolezal M, Polácek V: Hormonal profile of men with premature balding. Exp Clin Endocrinol Diabetes 2004, 112(1):24-28. doi:10.1055/s-2004-815723 doi:10.1055%2Fs-2004-815723 . PMID 14758568
• [21]Denmark-Wahnefried W, Lesko SM, Conaway MR, Robertson CN, Clark RV, Lobaugh B, Mathias BJ, Strigo TS, Paulson DF: Serum androgens: associations with prostate cancer risk and hair patterning. J Androl 1997, 18(5):495-500.
• [22]Ellis JA, Panagiotopoulos S, Akdeniz A, Jerums G, Harrap SB: Androgenic correlates of genetic variation in the gene encoding 5α-reductase type 1. J Hum Genet 2005, 50(10):534-537.
• [23]de Sousa IC VD, Tosti A: New investigational drugs for androgenetic alopecia. Expert Opin Invest Drugs 2013, 22(5):573-589.
• [24]Drake LA, Dinehart SM, Farmer ER, Goltz RW, Graham GF, Hordinsky MK, Lewis CW, Pariser DM, Webster SB, Whitaker DC, Butler B, Lowery BJ, Price VH, Baden H, DeVillez RL, Olsen E, Shupack JL, American Academy of Dermatology: Guidelines of care for androgenetic alopecia. J Am Acad Dermatol 1996, 35(3 Pt 1):465-469.
• [25]Ota Y, Iwamoto S, Kumagai N, Arakawa Y: Spontaneous two-photon emission from a single quantum dot. Phys Rev Lett 2011, 107(23):233602.
• [26]Lim CS, Masanta G, Kim HJ, Han JH, Kim HM, Cho BR: Ratiometric detection of mitochondrial thiols with a two-photon fluorescent probe. J Am Chem Soc 2011, 133(29):11132-11135.
• [27]Karu TI, Pyatibrat LV, Afanasyeva NI: A novel mitochondrial signaling pathway activated by visible-to-near infrared radiation. Photochem Photobiol 2004, 80(2):366-372.
• [28]Heger M, Heemskerk AA, van der Zwan G: Absence of 633-nm laser irradiation-induced effects on glucose phosphorylation by hexokinase. J Photochem Photobiol B 2010, 98(3):216-222.
• [29]Shorter K, Farjo NP, Picksley SM, Randall VA: Human hair follicles contain two forms of ATP-sensitive potassium channels, only one of which is sensitive to minoxidil. FASEB J 2008, 22(6):1725-173.
• [30]Vidali S, Knuever J, Lerchner J, Giesen M, Bíró T, Klinger M, Kofler B, Funk W, Poeggeler B, Paus R: Hypothalamic-pituitary-thyroid axis hormones stimulate mitochondrial function and biogenesis in human hair follicles. J Invest Dermatol 2014, 134(1):33-42.
• [31]Rossi A, Cantisani C, Scarnò M, Trucchia A, Fortuna MC, Calvieri S: Finasteride, 1 mg daily administration on male androgenetic alopecia in different age groups: 10-year follow-up. Dermatol Ther 2011, 24(4):455-461. doi:10.1111/j.1529-8019.2011.01441.x
• [32]Kritsky MS, Telegina TA, Vechtomova YL, Kolesnikov MP, Lyudnikova TA, Golub OA: Excited flavin and pterin coenzyme molecules in evolution. Biochemistry (Mosc) 2011, 75(10):1200-1216.
• [33]Karu TI, Pyatibrat LV, Kalendo GS: Cell attachment to extracellular matrices is modulated by pulsed radiation at 820 nm and chemicals that modify the activity of enzymes in the plasma membrane. Lasers Surg Med 2001, 29(3):274-281.