Coenzyme Q10 formulations in the treatment and prevention of epidermolysis bullosa
The present invention is directed, in part, to methods of treating Epidermolysis Bullosa (EB) in a subject in need thereof, comprising topical administration of a pharmaceutical composition comprising a therapeutically effective amount of a of Coenzyme Q10 (CoQ10) to the subject.
1 . A method of treating Epidermolysis Bullosa (EB) in a subject having one or more wounds associated with the EB between 2.5 cm 2 and 50 cm 2 in size, comprising topically administering a pharmaceutical composition comprising a therapeutically effective amount of Coenzyme Q10 (CoQ10) to the subject, thereby reducing the size of the one or more wounds associated with the EB.
2 . The method of claim 1 , wherein the Epidermolysis Bullosa is Epidermolysis Bullosa Simplex, Junctional Epidermolysis Bullosa, Dystrophic Epidermolysis Bullosa, or Kindler's Syndrome.
3 . The method of claim 1 , wherein the pharmaceutical composition comprising CoQ10 is administered for a treatment duration from about one week to about twelve weeks.
4 . The method of claim 1 , wherein the pharmaceutical composition comprising CoQ10 is administered to the subject from 1 to about 14 times per week for the treatment duration.
5 . The method of claim 1 , wherein the pharmaceutical composition comprising CoQ10 contains from about 1% to about 5% CoQ10 (w/w).
6 . The method of claim 1 , wherein administering the pharmaceutical composition comprising CoQ10 to the subject provides one or more beneficial effects to the subject, wherein the one or more beneficial effects is selected from the group consisting of:
a. Reduction in pain associated with the EB;
b. Reduction in inflammation associated with the EB;
c. Reduction in the number of blisters and/or wounds associated with the EB;
d. Increase in the rate of healing of one or more blisters and/or wounds associated with the EB;
e. Increase in the structural integrity of the skin of the subject suffering from EB;
f. Reduction in the number of skin infections associated with EB;
g. Increase in wound closure of wounds associated with EB;
h. Increase in re-epithelization of wounds associated with EB;
i. Increase in granulation of wounds associated with EB;
j. Reduction in an epidermal gap distance of a blister and/or wound associated with EB;
k. Reduction in time for blister and/or wound healing associated with EB;
l. Reduction in the amount of concomitant medications administered to the subject in order to treat the subject's EB;
m. Reduction in scarring associated with EB;
n. Increase in keratinocyte production in the skin of the subject; and
o. Increase in fibroblast production in the skin of the subject.
7 . The method of claim 1 , wherein the pharmaceutical composition comprising CoQ10 is administered in the form of a CoQ10 cream at a dosage of CoQ10 between 0.01 mg/cm 2 and 5 mg/cm 2 .
8 . The method of claim 1 , wherein the pharmaceutical composition comprising CoQ10 is administered with a second composition comprising an additional agent.
9 . The method of claim 1 , wherein the pharmaceutical composition further comprises an additional agent.
10 . The method of claim 1 , wherein treatment of the subject results in the reduction of size of one or more blisters and/or wounds by at least about 70% after administration of an effective amount of CoQ10 for a treatment duration of about four weeks.