Im going to cut and paste and comment:
First, the HUMAN SKIN EXAMPLE IN THE PATENT:
Example 7: EDIHN induces new hair follicles in human skin. Grafting. Discarded human adult scalp from the preauricular area obtained from plastic surgery was grafted onto immunodeficient (scid) mice. The graft was bandaged and allowed to heal, then was used in the wound healing study 3 months after grafting.
Results: To determine whether human skin responded to EDIHN as did mouse skin, human skin was grafted onto SCID (immuno-defϊcient) mice and subjected to depilation by plucking and wound induction three days later. Seven days following wound induction, formation of new HF was observed in the human skin (Figure 2 IA; arrows indicate new HF) by hematoxylin and eosin staining of paraffin embedded tissue sections.
In additional experiments, adult human skin was grafted onto mice, abraded, and examined at 7 days post-abrasion. New HF were generated in the human skin, which mimicked normal hair follicle formation during fetal development, as evidenced by staining for S100A6 or S100A4 (Figure 21B).
What this means is that hair GERMS were detected in human skin. One would not be seeing hairs sprout at this time, that would be a few weeks later for certain. Probably 3 weeks or so later anyway.
The results of this Example show that EDIHN can be used to generate hair growth in human skin as for mouse skin
This is the verbiage I thought was “essential” as to know what they are doing. This is an incredibly defensively written patent. They are attempting to patent any and every possible embodiment as to make sure no doctors can perform this and not pay Follica royalties for it. Some of the stuff in the patent probably wouldn’t work or help at all.
■ …characterized by detachment of the scab. Depending on the depth of the abrasion process, it may be desirable for the compounds of the invention to be administered or activated prior to or after the detachment of a scab. Alternatively, hair follicles may start to form before the scab falls off, in the case of, for example, dermabrasion.
Alternatively the compounds of the invention can be administered prior to epidermal disruption. In such embodiments, the compound may be formulated for controlled release such that the therapeutically active compound is released during reepithelialization or during a particular phase of
reepithelialization (e.g., as described above. The compound may also be formulated such that it becomes activated by an endogenous or exogenous stimulus (e.g., as desribed below). I highly doubt this…In all probability they are not going to fool with some sort of time release drug topically. They will probably wound the dermis, wait for skin re-epilithialization, and around day 5, apply their topical for five or six days. That will probably be it. [/color]
Induction of reepithelialization
The state of reepithelialization can be induced. Methods of inducing this state include the disruption of the subject’s skin at the location where the compounds of the invention are going to be administered. Disruption can be achieved through abrasion (e.g., the rubbing or wearing away of skin), or through any method that results in disturbing the intactness of the epidermis or epidermal layer including burning (e.g., by inducing a sunburn) or perforating the epidermis or epidermal -layer: The disruption can either result in partial or complete removal of the epidermal layer at the intended location.
The disruption of the epithelial layer can be accomplished, for example, through mechanical, chemical, electromagnetic, electrical, or magnetic means. Mechanical means can be achieved through the use of, for example, sandpaper, a felt wheel, ultrasound, supersonically accelerated mixture of saline and oxygen, tape-stripping, or peels.
Chemical means of disruption of the epidermis can be achieved, for example, using phenol, trichloracetic acid, or ascorbic acid.
Electromagnetic means of disruption of the epidermis can be achieved, for example, by the use of a laser capable of inducing trans-epithelial injury (e.g., a Fraxel laser, a CO2 laser, or an excimer laser). Disruption can also be achieved through, for example, the use of visible, infrared, ultraviolet, radio, or X-ray irradiation.
Electrical or magnetic means of disruption of the epidermis can be achieved, for example, through the application of an electrical current or through electroporation. Electric or magnetic means can also include the induction of an electric or a magnetic field. For example, an electrical current
can be induced in the skin by application of an alternating magnetic field. A radiofrequency power source can be coupled to a conducting element, and the currents that are induced will heat the skin, resulting in an alteration or disruption of the skin. In this embodiment, no external energy transfer is needed in order to cause a disruption
Any of the previously mentioned means of disruption can be used to induce for example, a burn, excision, or microdermabrasion.
Optionally, the skin, following the epidermal disruption, is not contacted for a period of time with any substance (e.g., ointment, a bandage, or a device) that is normally administered to an abrasion or wound to prevent infection.That paragraph is very important. You will screw it all up if you aren’t careful and get nothing. I’d suggest doing absolutely nothing post wounding, except maybe water-washing. In fact…I think Id wear a hat for a few days and not even wash the hair until the chemicals have been applied
Here the skin is not contacted with any substance until, for example, the ■ •■ - epidermal disruption -has healed (e.g., any time between 2 days and 3 weeks). Alternatively, the skin can be contacted with a cast or bandage (e.g., resulting in increased blood flow to the disrupted skin or decreased transdermal water loss or decreased mass transfer of gases into the skin and from the skin (e.g. oxygen, carbon dioxide, water vapor), decreased heat transfer from the skin (e.g. resulting in an increased temperature of the skin surface) or increased pressure on the skin.
Prior to disruption, the skin can depilated or epilated. The depilation or epilation can be accomplished through, for example, waxing, plucking, an abrasive material, a laser, electrolosis, a mechanical device, or thioglycolic acid.
The disruption of the epidermis can be induced between 3-12 days (e.g., 4-12, 5-12, 4-11, 6-11, 6-10, 6-9, 7-8, 5-11, 5-10, or 7-10 days) prior to the addition of the compositions of the invention. I think FIVE DAYS because hair germs were detected in human skin at day 7. They probably started forming by day 6 at the latest.
Any of the above-described methods may be used to remove a precise amount of epidermal tissue. For example, the methods of abrasion described herein may be used to achieve:
• Removal of the stratum comeum through removal of the first 10-30 μm of dead skin cells.
• Removal of the stratum corneum and part or all of the epidermis by removing the first 30-100 μm of the skin. This is not deep enough to remove the sebaceous gland, bulge, or hair papilla of existing follicle structure
