A Discussion of Industry Knowledge
The Treatment of Androgenetic Alopecia with LLLT Devices
Introduction
Name | Wavelength | Name | Wavelength |
Gamma Ray |
< 0.01 nm |
Visible |
380 nm – 700 nm |
X-ray |
0.01 nm – 10 nm |
Infrared |
700 nm – 1 mm |
Ultraviolet |
10 nm – 380 nm |
Microwave |
1 mm – 1 meter |
Indications for Use, Regimen, and Risks of Use
-
- All systems are products that form a group of devices called Low-Level Laser/Light Therapy devices.
- All systems contain semiconductor laser diodes and/or LEDs that operate at a similar wavelength for visible red light from the Electromagnetic Spectrum.
- All systems have the same IEC (International Electrotechnical Commission) classification for laser products – Class IIIa/3R
- All systems have the same safety and adverse effect profile.
- All systems have the same Common Name – Lamp, non-heating for promotion of hair growth.
- All systems have similar treatment protocols – 3-4 times per week on non-consecutive days for 16 – 26 weeks (to see noticeable first results; to maintain results, the device is intended to be used indefinitely).
Table 1: Current Laser Devices
Product | Company | Approval Date | 501 (K) Number | Product Code |
Capillus82 |
Capillus, LLC |
08/21/2015 |
K151516 |
OAP |
Lasercap LC pro LC Elite 18 |
Transdermal Cap, Inc. |
07/22/2015 |
K150613 |
OAP |
Capillus272 OfficePro |
Capillus, LLC |
06/09/2015 |
K150578 |
OAP |
LX-100 Hair Growth Stimulation Systema |
HairLabs International, Inc. |
04/14/2015 |
K142824 |
OAP |
Capillus272 Pro |
Capillus, LLC |
01/29/2015 |
K143199 |
OAP |
Nutra Stim Laser Comb |
NutraLuxe MD, LLC |
01/08/2015 |
K141588 |
OAP |
Nutra Stim Laser Comb |
NutraLuxe MD, LLC |
01/08/2015 |
K141596 |
OAP |
iGrow II Hair Growth SYS |
Apira Science, Inc. |
12/05/2014 |
K140931 |
OAP |
HairMax LaserComb |
Lexington International, LLC |
12/01/2014 |
K142573 |
OAP |
iGrow II Hair Growth SYS |
Apira Science, Inc. |
08/21/2014 |
K141567 |
OAP |
Sunetics Clinical Bio-Stim Laser |
Sunetics International, LLC |
12/20/2013 |
K132646 |
OAP NHN |
Laser Brush |
Sunetics International, LLC |
06/27/2013 |
K121920 |
OAP |
Laser Helmet |
Theradome Inc. |
06/14/2013 |
K122950 |
OAP |
iGrow II Hair Growth SYS |
Apira Science, Inc. |
12/05/2012 |
K122248 |
OAP |
Laser Helmet |
Theradome Inc. |
03/02/2012 |
K113097 |
OAP NHN |
HairMax LaserComb |
Lexington International, LLC |
09/26/2011 |
K112524 |
OAP |
HairMax Dual 12 |
Lexington International, LLC |
08/16/2011 |
K111714 |
OAP |
HairMax LaserComb |
Lexington International, LLC |
05/27/2011 |
K110233 |
|
HairMax LaserComb |
Lexington International, LLC |
04/06/2011 |
K103368 |
OAP |
E-Light Line |
Espansione Marketing S.P.A |
09/20/2010 |
K092734 |
OAP GEX ISA |
MEP-90 Hair Growth System |
Midwest R.F., LLC |
02/23/2010 |
K091496 |
OAP |
HairMax LaserComb |
Lexington International, LLC |
11/23/2009 |
K093499 |
OAP GEX |
HairMax LaserComb |
Lexington International, LLC |
01/18/2007 |
K060305 |
OAP |
This brings us to a discussion of Arndt-Schultz Law (Figure 5), which claims: For every substance, small doses stimulate, moderate doses inhibit, and large doses may terminate life processes. With low-level laser therapy, we strive to accomplish biostimulation; defined here as the “small” dose. If we raise the intensity of light delivered (significantly), the result is permanent hair removal; think of this as the “large” dose. Alternatively, when a user thinks that more frequent or longer treatments will yield better results; it is in fact, the opposite. However, the result is not permanent (at least not in the short term). To complete our example, the latter would be the “moderate” dose. Thus, there is specific instruction by manufacturers of LLLT devices; that is:
Follow the use instructions! Do not use more often or for longer periods than prescribed!
Figure 5: Arndt-Schultz Law
A study conducted by a neutral third party for Capillus, LLC, demonstrates that low-level laser treatment of the scalp every other day for 17 weeks using the Capillus272 Pro device is a safe and effective treatment for androgenetic alopecia. ClinicalTrials.gov Identifier: NCT01967277. Subjects receiving LLLT at 650 nm achieved a 51% increase in hair counts as compared to sham treated control patients. Active Treatment Group Subject Pre and Post Treatment Images are presented in Figures 6 and 7.
Figure 6: A 53 year-old Caucasian female, Fitzpatrick skin phototype III, Ludwig-Savin 1-3, with a history of androgenetic alopecia. This subject was enrolled into the active test device group. After 17 weeks of compliant home-use treatments, she returned for her final photography and release from the trial.
Primary Response
The formatted photographs were submitted for terminal hair counting. In the pre-treatment image, 39 terminal hairs were counted. In the post-treatment image 87 terminal hairs were counted. This demonstrates a 123% increase in terminal hairs from baseline.
Figure 7: A 49-year-old Caucasian female, Fitzpatrick skin phototype II, Ludwig-Savin 1-1, with a history of androgenetic alopecia. This subject was enrolled into the active test device group. After 17 weeks of compliant home use, treatments she returned for her final photography and release from the trial.
Primary Response
The formatted photographs were submitted for terminal hair counting. In the pre-treatment image, 97 terminal hairs were counted. In the post-treatment image 153 terminal hairs were counted. This demonstrates a 57% increase in terminal hairs from baseline.
Are Men and Women Created Equal?
The final part of this discussion focuses on gender, specifically, the question whether there is a difference between men and women with regard to the physical function of hair regrowth. This investigator could find no published empirical evidence or reference regarding hair regrowth as a gender specific function, other than pattern, i.e., the form in which hair is lost. We could find no scientific paper postulating that there is a difference in the physical function of hair growth for men vs. that for women. Overall thinning is more prevalent in women, and “receding hairline” or “monk’s spot” are more common in men; however, for external strategies for regrowth (i.e., LLLT), there are no published differences in industry literature.
There is also a lack of published data specifically regarding the treatment (or difference in treatment) of androgenetic alopecia in women vs. men; this very lack of such discussion gives credence to the argument that there is no difference. The only discussions regarding gender are focused on the differences between the patterns of hair loss, and the increased likelihood with women that hair loss is attributable to reasons other than genetics.
Any reference to treatment difference between men and women is limited to the use of drugs and topicals which target specific hormones which do present differently between the genders. When asked, Dr. Shelly Friedman stated that with regard to low-level laser therapy, he prescribes essentially the same treatment regimen for men and women who present with androgenetic alopecia. Capillus, LLC, postulates this lack indicates there is no difference with regard to the physical function of hair regrowth, other than the normal differences found in individuals; that is to say, treatment regimen is adjusted by physician prescription based on each individual’s needs, not specific to gender.
Physicians use a system known as the Norwood-Hamilton Classification (for men) and the Ludwig-Savin Scale (for women) to describe the degree of hair loss. Devices cleared by the FDA for low-level laser therapy are intended for promotion of hair growth in males who have Norwood Hamilton Classifications of IIa to V and in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and have Fitzpatrick skin phototypes I to IV.
This is the main reason Capillus LLC sells only to licensed health care providers rather than over the counter – to ensure the device is used by patients diagnosed with androgenetic alopecia and that these patients have medical advice with regard to optimal regimen.
In the clinical trials for LLLT devices reviewed for this paper, the treatment regimen between genders are the same. This also supports the premise that there is no difference between men and women with respect to the physical function of hair growth.
The following excerpts are intended to represent a consensus of available data.
(References are listed at the end of this page.)
The [present study] demonstrates that that low level laser (light) treatment of the scalp every other day for 16 weeks using the [XXX] device is a safe and effective treatment for androgenetic alopecia in healthy women … with Fitzpatrick Skin Types I–IV and Ludwig–Savin Baldness Scale I-2–II-2 baldness patterns. Subjects … achieved a 37% increase in hair counts as compared to sham treated control patients. These results are similar to those reported in an earlier study using the same device in males with alopecia. [From the clinical results published for iGrow, K140931.]
“Androgenetic alopecia (AGA), also known in women as female pattern hair loss, is caused by androgens in genetically susceptible women and men. The thinning begins between ages 12 and 40 years, the inheritance pattern is polygenic, and the incidence is the same as in men.”[40]
“In susceptible hair follicles, dihydrotestosterone (DHT) binds to the androgen receptor, and the hormone-receptor complex activates the genes responsible for the gradual transformation of large terminal follicles to miniaturized follicles. Both young women and young men with AGA have higher levels of 5 reductase and androgen receptor in frontal hair follicles compared to occipital follicles.”[40]
“Low level laser therapy is a safe form of light treatment used to treat the genetic forms of hair loss common in men and women, androgenetic alopecia or pattern balding.”[43]
Androgenetic alopecia can affect up to 70% of men (male pattern balding) and 40% of women (female pattern balding) at some point in their lifetime. While men typically present with a distinctive alopecia pattern involving hairline recession and vertex balding, women normally exhibit a diffuse hair thinning over the top of their scalps. [Various]
“Low level laser therapy (LLLT) uses devices with diodes that emit red light (wavelength range from 630-670 nanometers), and are available 1) in-salon hoods or overhead panels, 2) as bonnet or head caps, and 3) as hand-held devices.”[47]
“Low level laser therapy is intended for men and women with thinning hair or pattern baldness caused by a hereditary condition.”[49]
The hair growth cycle consists of three phases: growth (anagen phase), resting (telogen phase) and shedding (catagen phase). Hair loss in androgenetic alopecia depends on a testosterone derivative in the skin, dihydrotestosterone (DHT). Low-level laser therapy is believed to increase blood flow in the scalp and stimulate metabolism in catagen or telogen follicles, resulting in the production of anagen hair. In theory: The photons of light act on cytochrome o oxidase leading to the production of adenosine triphosphate (ATP). This is converted to cyclic AMP in the hair follicle cells, releasing energy and stimulating metabolic processes necessary for hair growth. Release of nitric oxide from cells leads to increased vascularization to the scalp distributing nutrients and oxygen to the hair roots. Excessive build-up of DHT is prevented. [Various]
Laser hair therapy may be delivered in a salon by professionals trained in its administration, or at home. Two to three times weekly treatments are typically recommended, and consist of an 8 to 40-minute exposure of the scalp to light-emitting diodes under a bonnet or head cap or using a handheld comb or brush. [Various references to treatment regimens, paraphrased]
Conclusion:
Benefits of laser therapy for hair loss: 1) Low-level laser therapy can be used in both men and women; 2) No adverse effects have been reported; and 3) It is clean and painless.
These results suggest that the emerging technology of Low-Level Laser Therapy may play a potentially significant role in health care providers’ armamentarium for the disease androgenetic alopecia (AGA).
² Hopkins J. T., McLodat T. A., Seegmiller J. G., Baxter G. D.: Low-Level laser therapy facilitates superficial wound healing in humans: A triple-blind, sham-controlled study. J Train. 2004; 39(3):223-229.
³ Schindl A., Schindl M., Schindl L. Successful treatment of a persistent radiation ulcer by low power laser therapy. J Am. Acad. Dermatol. 1997; 37(4): 646-648.