"The First Electrology Standards in the World"

For the Treatment of Permanent Hair Removal

"To Protect The Patient As
Well As The Practitioner"

Prepared by: Fino Gior, Founder, December 8, 1978
Paul Kechijion, MD., Dermatology Consultant
Revised, 1983, 2001
Copyright 8/15/95 Fino Gior

 

I. DEFINITION: Electrology is the only process of destroying the hair follicle with an electrical current, for the purpose of permanent removal of hair, safely and economically. It is accomplished by the destruction of the dermal papilla and the surrounding germinative cells in the lower two thirds of the hair follicle.

The electrologist inserts a very fine probe alongside the hair in the hair follicle. A very slight amount of electrical current is then applied through this probe which destroys the hair root, permanently ending further hair growth. The skin is not punctured or harmed in any way.

II. PURPOSE: This document sets forth acceptable equipment and techniques for permanent removal of hair. A process alleged to be effective must remove permanently at least 50-60% of the hairs on initial treatment, 60-70% should be an average, with, possible highs of 70-80%. The increase of percentages would be proportionate to the proficiency of the practitioner.

III. RESEARCH AND BACKGROUND: *(1, 2, 3, 4, 5, 6 and 7). The equipment and techniques were tested, studied and researched over a 44 year period. The experience and knowledge of expert Electrologists, corroborated by qualified Dermatologists, Pathologists and Electrical Engineers, so enact these standards.
The hair removal processes tested and researched were: Depilatory lotions, Waxes, Tweezing, Shaving, Photoepilation, Electrified Tweezers and Electrified Needles (Thermolysis and Electrolysis), and a combination of Thermolysis and Electrolysis devices.

In the 1980s the first laser device was introduced into the permanent hair removal profession. It was an argon laser that never caught hold because it never proved to be effective, it was very costly and the equipment was very large.

A laser device may contain a gas or mineral such as carbon or ruby crystal and when stimulated with the proper electric current the atoms will focus a cohesive light beam that will react with anything black.

The beam will vaporize the black hair, but will not have any effect on blond, gray or vellus hair. The theory is that if there is enough of the pigment melanin in the follicle itself there would be permanent follicle destruction. Unfortunately there is not enough melanin in the hair follicle to cause substantial amounts of permanent tissue destruction. Dark, tan, and black skins must avoid laser treatment due to severe burning and long lasting hyperpigmentation effects to the skin.

This is why, in my opinion, the FDA Medical Device Division gave clearance for a few of these devices to advertise, "Permanent Reduction". 'There is a little destruction but not enough to call it Permanent.

Laser Device

 

To date the laser has not proved itself to be as sufficiently effective as needle type electrology. In most cases that I have examined there was no permanent hair removal at all.

 

Laser Treatment

See VI FURTHER CONSIDERATIONS
(below)
 

U .S. Government, Paul R. Beninger, M.D., Director Food & Drug Administration, Medical Device Division.

"…The terms permanent, painless or long term effect are not acceptable terms when describing these devices."

The Wall Street Journal, "Health Journal", Marilyn Chase

"Laser hair removal is pricey and popular but not permanent."

American Academy of Dermatology, Medscape Inc., CBS Health Watch, Eric Sabo

Dr. David Friedman says, "Dermatologists shouldn't promise patients Permanent Hair Removal, by using Laser or their money back. You'll probably find yourself out of business.

 

Light Device

Fino Demonstrating Electronic Tweezer and Electrolysis Devices with Regis Philbin

 

ELECTRONIC TWEEZER Federal Code Regulations
(Alleged Noninvasive Method)

57060 Federal register/revised October 8, 1998,
Rules and Regulations
D.B. Burlington, Director for Devices and Radiological Health
FR Doc. 98-28579 Filed 10-23-98, 8:45am
2. Section 878.5360


Electronic Tweezer

FDA has now designated electronic tweezers, radio frequency, galvanic or a combination of both currents has defined that these devices do not destroy the dermal papillae and will not cause permanent hair removal. This reverses the previous FDA identification statement and this is a final ruling. (2) 21 CFR 878.5350

If The Food and Drug Administration, Medical Devices Division, and the Federal Trade Commission satisfactorily test any other alleged process of permanent hair removal and find that the process meets these standards, the AECA will accept them as qualified devices.

IV. PROCEDURES FOR EVALUATING ALLEGED PROCESSES FOR PERMANENT HAIR REMOVAL.

(1) The investigator must be a AECA qualified electrologist with no less than two years experience and a staff member of the Advanced Electrology Center of America.

(2) The electrified needle method must be a "Federal Communications Commission" and "F.D.A. , Medical Device Division" approved device.

(3) Subject: male or female, between the ages of 20 years and 30 years.

(4) Test area: Anterior shin.

(5) For control purposes 100 terminal hairs are to be removed within a very concentrated area, using an electrified needle; and in close proximity, 100 terminal hairs are to be removed by the test method.

(6) The control and test sites are to be carefully examined weekly for 12 weeks. Hairs appearing within 14 days are to be considered early anagen hairs, that were not visible during the test treatment, which will be charted and not considered regrowth. Regrowth hair is hair which emanates from treatment follicles.

(7) After 12 weeks results will be recorded and efficacy will be determined.

(8) An AECA Staff Member must be present for each step. A notarized affidavit must be signed by two witnesses and the AECA Staff Member, to be a valid evaluation.

V. QUALIFIED EQUIPMENT*

As researched and tested, the only processes that meet the 50-60% minimum for permanent hair removal, are electrified needles. They operate by 3 modalities: Galvanic or Electrolysis, (high frequency), Short Wave or Thermolysis and a combination of both through one probe.

(a) Galvanic-Electrolysis is a procedure which utilizes a chemical effect. A caustic reaction occurs destroying the dermal papilla and surrounding germinative cells. Human tissue contains a composition of salt water and protein. Through Galvanic current, sodium hydroxide, lye or caustic soda in solution is formed which destroys the living cells in the surrounding tissues.

2 NaCI + 2H2O Galvanic Electrolysis-----> H2 + 2CI + 2NaOH

SALT + WATER——> HYDROGEN GAS + CHLORINE GAS + SODIUM HYDROXIDE

(b) HF-Short Wave-Thermolysis is a heat procedure. A field of high speed electrons is generated along the needle which through friction heats up the water molecules inside the hair follicle and papilla, which in turn coagulates (127°F), or desiccates (212°F), the surrounding tissue and germinative cells.

(c) Combination - (1) This method utilizes both Thermolysis and Electrolysis. The "Blend Technique" is basically a Galvanic procedure reinforced by the heat of thermolysis simultaneously. (2) Sequential is a technique where the thermolysis and electrolysis are activated in the hair follicle in sequence of each other (one at a time).

VI. FURTHER CONSIDERATIONS: *1, 2, 3, 4, 5, 7,

Tweezing hair can cause 1 % permanent removal. Over many years of retweezing the hairs from the same follicle, a 5% permanent removal can be accomplished. Unacceptable devices use these percentages mistakenly as proof of their effectiveness. This could be true of fine hair on the upper lip, underarm hair, eyebrows and a portion of the leg hair from the ankle upward but not further than the middle of the leg between the knee and ankle. Fine hair- lanugo or vellus hair- when tweezed, can take up to 3 months to regrow. Constant tweezing can delay the growth even further, which may be misinterpreted as permanently-removed hair. Experience has shown that while some hairs may be permanently removed by tweezing, most of the hair that does regrow, grows back thicker in diameter as compared to an untweezed hair of the same hair follicle. It should be noted that many persons over 40 years of age tend to have a natural hair loss in the eyebrows, underarms, legs and scalp, but an increase in hair growth can occur on the face at this same time. On women it is called Menopausal Hair Growth causing the syndrome Hirsutism or male pattern hair growth.

VII. STIMULATING GROWTH: *(7) Electrified Needles have shown no tendency to stimulate surrounding dormant hair follicles to grow hair.

VIII. DEPILATORY CREAMS AND SHAVING: *3, 7 have demonstrated no effect whatsoever on the hair growth cycle.

 
RESEARCH BIBLIOGRAPHY

*(1) ERICH LUDWIG, M.D., "Removal of Intact Hair Papilla and Connective Tissue Sheath by Plucking Anagen Hairs." The Journal of Investigative Dermatology, Vol. 48, The Williams J. Wilkins Co., pp 595, 596, 1967.

(2) ERICH LUDWIG, M.D., "Separation of the Hair from its Papilla and Connective Tissue Sheath in Plucked Anagen Hairs." Montagna-Dobson, "Advances In Biology of Skin," Vol. IX, "Hair Growth," Pergamon Press, 1967.

(3) LEE McCARTHY, M.D., "Diagnosis and Treatment of Diseases of the Hair," "Hypertrichosis," "Acquired Localized Hypertrichosis," "Etiology," "Transitory Hypertrichosis Treatment," C.V. Mosby, 1941.

(4) FRED F. CASTROW II, M.D., James R. Givens, M.D., Marvin A. Kirschner, M.D., "Hirsutism, When a Woman Wants Epilation," "Patient Care, pp. 60-88, Sept. 30, 1977.

(5) R.J. MEYERS AND J.B. HAMILTON, M.D., "Regeneration and Rate of Growth of Hairs in Man," Annals of the New York Academy of Sciences, March 1951.

(6) GORDON BLACKWELL, "Normal Hairs and Follicles" Part II, The Quantity and Distribution of Follicles, Electrolysis Digest, Vol. XXV, No. 2, pp. 33, April 1978.

(7)  FINO GIOR, Personal data, "Time Areas" AECA Form, Feb. 1970; Regrowth Patterns AECA Form 103, Jan. 1976; Combined Tests with the Orentreich Foundation for the Advancement of Science, Inc. Oct. 28, 1975.

 

 

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