Inhibiting DHT as a Treatment for Hair Loss

Androgens are steroid hormones produced and secreted into the systemic circulation by the testes, ovaries, and adrenal gland.  Androgens like testosterone and 5α-dihydrotestosterone (DHT) in the skin are the main cause of androgenetic alopecia or “pattern baldness”.  Based on results from laboratory testing, red light triggered release of nitric oxide may inhibit steroidogenesis and the production of DHT.

By reducing androgen levels locally in skin, photoinitiated release of nitric oxide provides a natural, locally acting DHT inhibitor for use in the treatment of androgenetic alopecia for both men and women.

Androgenetic Alopecia and Androgens

Androgenetic alopecia is one the most prevalent skin conditions in the United States affecting over 80 million Americans.  The development of androgenetic alopecia depends both on personal genetic makeup, environmental risk factors, and the quantity of androgen receptors in the skin.  In fact, balding is NOT observed in individuals that lack a functional androgen receptor or in men with 5α-reductase deficiency, the enzyme that converts testosterone to the more potent androgen, dihydrotestosterone (DHT) (PMID: 23016593).

DHT accelerates the rate at which hair follicle miniaturization takes place, i.e., as new hair follicles are generated they are smaller than their predecessors eventually leading to miniaturized follicles that do not support hair growth (PMID: 21206086).  Inhibition of DHT production in the skin has been shown to be effective in treating receding hair lines and other forms male pattern baldness with the FDA approved 5α-reductase inhibitor, finasteride (Propecia®) (PMID: 10365924).

Androgens direct the development of male reproductive tissues during fetal and pubertal development and promote the development of male sexual characteristics such as increased muscle and bone mass, the growth of body hair, deepening of the voice, and sexual arousal.  (Which is why, if chemicals interfere with these natural pathways, there can be sexual side effects and the prescription drug finasteride is not approved for use in women.)

Androgen Biosynthesis in the Skin

The chemical structure of dihydrotestosterone.

A major breakthrough was made when it was discovered for the first time that the skin, as an organ, can actually synthesize androgens de novo from cholesterol or by locally converting circulating weaker androgens into more potent androgens like testosterone and DHT (PMID: 23435015).  The local production of androgens in the skin can be regulated up and down by locally produced hormones or other inflammatory signaling molecules called cytokines that respond to pathogens or environmental stimuli in the scalp.  In fact, it has been documented that skin from patients with male pattern baldness (PMID: 2091154) produces higher amounts of testosterone and DHT than skin from healthy individuals (PMID: 11348472).

Summary of mechanisms by which nitric oxide can inhibit androgen synthesis and DHT in the skin

In the steroid biosynthetic pathway, nitric oxide inhibits P450 enzymes, namely, cholesterol sidechain cleavage enzyme (PMID: 12242026), 17α-hydroxylase/C17-20-lyase (PMID: 9492021), and aromatase (PMID: 8809186), presumably by interacting with the iron residue bound in the active site of P450.  Since de novo androgen production in the skin requires all these enzymes, inhibition of these protein functions can reduce skin androgen levels.

Nitric oxide may also inhibit the activity of 5α-reductase, the enzyme that converts testosterone to the more potent androgen DHT.  A critical and highly conserved thiol residue in the active site of the 5α-reductase enzyme is susceptible to nitrosation and inactivation by nitric oxide.  Studies have demonstrated the ability of nitric oxide to inhibit 5α-reductase enzymatic activity in vitro in a dose dependent manner.  The inhibition observed was comparable to the inhibition of DHT formation observed with a 1 micromolar concentration of finasteride.

We believe that the 5α-reductase inhibitory activity of nitric oxide can be best stimulated through dual wavelength LED therapy as a natural, hormone free treatment for androgenetic alopecia.

REVIAN® RED Light Therapy Safe and Effective for Hair Growth

DURHAM, N.C.–(BUSINESS WIRE)– PhotonMD, Inc., a technology company specializing in the advancement of precise light based medical treatments, today announced positive topline results from a pivotal clinical trial assessing a series of hair growth devices, including REVIAN® RED, an all-LED cap for the treatment of androgenetic alopecia (“pattern hair loss”). In the randomized, double-blind, placebo-controlled trial, REVIAN RED successfully demonstrated the ability to stop hair loss and subsequently grow new hair. This treatment functions as an effective alternative to chemical-based topicals and prescription drugs.

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Androgenetic alopecia is a common form of hair loss affecting an estimated 50 million men and 30 million women in the United States.1 Male pattern hair loss is typically characterized by a receding hair line or balding of the crown, while female pattern hair loss appears as overall thinning or widening of the midline. Current FDA regulated treatment options include topical minoxidil, oral finasteride for men, and low-level laser light therapy (LLLT).

“It took almost 20 years to work out the ideal wavelengths of light, the best fluence or ‘power’, how long the treatments should last and how often the treatments need to be repeated. That sort of information requires clinical trials and that is exactly what we have done here,” stated Dr. Rodney Sinclair, Principle Investigator, Dermatologist and Professor of Medicine at Melbourne University. “We specifically designed this clinical trial with the rigor of a pharmaceutical trial. We used the same primary and secondary endpoints as were used in finasteride and minoxidil studies. We used placebo caps. Participants and evaluators were blinded and as an outcome, these results can be trusted.”

Trial patients were randomly provided either a light-based hair growth treatment or placebo cap (no light therapy) and treated 10 minutes per day for up to 26 weeks. Patients eligible for this clinical trial were adult males or females, 18 to 65 years of age with diagnosis of androgenetic alopecia. Participants agreed to refrain from using all other hair growth products or treatments (oral or topical medication including over the counter herbal medications) during the study.

The primary endpoint for this clinical trial was the mean change in target area hair count between active and sham treated subjects at week 16. Total hair counts were obtained from computer assisted scans of digital photographs taken of a defined target area (1 cm2) centered around a tattoo located in the anterior mid area of the scalp. The efficacy evaluable population was defined as participants who completed at least 16 weeks of treatment, had no major protocol violations, and who were at least 80% compliant with the 10 minutes per day treatment regimen for the duration of the trial.

After 16 weeks, trial participants that treated with the red light therapy and were at least 80% compliant (n=18) had an average of 21.3 more hairs per cm² compared to where they started than those participants who wore a placebo cap but received no light therapy (n=18). Subjects treated with the placebo cap continued to lose hair over the duration of the study.

The safety of REVIAN RED was carefully monitored and recorded. There were no treatment discontinuations due to an adverse event and there was no device related serious adverse events reported in the trial for any of the treatment arms. In the safety population, there was also a trend toward more hair growth for REVIAN RED than placebo.

“These results are impressive. The total hair counts and excellent safety profile of REVIAN RED is encouraging for patients suffering from pattern hair loss,” said Dr. David McDaniel, Dermatologist and Director of the McDaniel Institute for Anti-aging Research. “Importantly, REVIAN RED represents an alternative first-line treatment option to topical minoxidil and oral finasteride, which have been generically available for a while now. Patients want more hair, and red light therapy affords them that opportunity without the use of pharmaceuticals.”

About REVIAN RED
The REVIAN RED System is an FDA cleared, completely wireless cap that is controlled by a mobile phone app. The rechargeable battery-operated cap functions to provide a hair loss treatment for men and women using modulated light therapy (MLT). The selection of precise LEDs with high output provide broader scalp coverage and better skin penetration than red lasers used in low level laser therapy (LLLT). Precisely selected, dual wavelengths of LED light facilitate and accelerate scalp healing, allowing the body to renew cells associated with hair growth and retention. For more information, visit the product website at www.revian.com.

Indications for use: The REVIAN RED System is indicated to treat androgenetic alopecia and to promote hair growth in males who have Norwood-Hamilton classifications of IIa – V patterns of hair loss and to treat androgenetic alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I – IV.

PhotonMD® Announces Commercial Sales of REVIAN® RED System

PhotonMD, Inc., an innovative photomedicine device company, announced its REVIAN RED system, an FDA cleared, over-the-counter (OTC) light therapy system for the treatment of androgenetic alopecia in both men and women is now shipping to customers.

“We have been greatly encouraged by the enthusiasm surrounding the launch of REVIAN RED and are excited to offer our treatment solution to help the 80 million Americans living with androgenetic alopecia, or pattern hair loss. It is important to give patients a convenient, effective, and safe solution without negative side effects for this chronic and progressive condition,” states President and Chief Executive Officer, Dr. Nicholas Medendorp, Jr.

The REVIAN RED system uses a wireless smart Cap and companion mobile app controller to stimulate natural hair growth in just 10-minutes a day. The revolutionary medical device combines a proprietary application of specific wavelengths of light with a first-of-its-kind smartphone mobile app (iOS or Android) allowing patients to control, schedule and monitor their daily 10-minute treatments for an effortless regrowth experience.

“The REVIAN RED system is offered at $749 and is an exceptional choice for men and women who are seeking a chemical-free hair growth solution in the privacy of their own home with zero mess or side effects,” said Medendorp.

REVIAN RED is available with a special launch discount for a limited time at REVIAN .com through its secure and simple checkout process. Restore your hair and your confidence. REVIAN .com

About PhotonMD:

REVIAN RED SystemPhotonMD is a modern medical device company focused on identifying and developing natural, chemical free, non-UV containing light technologies that will enable the treatment of chronic diseases. The products treat various health conditions using Modulated Light Therapy™ (MLT) technology that play an important role in unlocking key elements in human physiology. The company is dedicated to pushing the boundaries of scientific research around light-based therapy and designing innovative and safe solutions that dramatically improve the lives of patients. For more information about PhotonMD, please visit PhotonMD.com.

Forward-looking Statements:
Except for historical information, all the statements, expectations, and assumptions contained in this press release are forward-looking statements. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: reliance on key personnel; the early stage of our business; risks associated with the medical device development processes; competition; and other risks described in other Company press releases and presentations. PhotonMD assumes no obligation and do not intend to update these forward-looking statements, except as required by law.