Compositions and methods for the treatment of skin lesions

1. A topical composition, wherein the composition comprises:

a) about 0.5% to about 5% 5-fluorouracil or a salt or hydrate thereof;

b) about 0.001% to about 0.01% calcipotriene or a salt or hydrate thereof; and

c) about 1% to about 5% diclofenac or a salt or hydrate thereof.

2. The topical composition of claim 1 , wherein the composition is formulated as an ointment, a cream, a lotion, a scalp lotion, a suspension, a powder, a solution, a paste, a spray, an aerosol, an oil, an oil in water emulsion, a liniment or other spreadable liquid or semi liquid preparation.

3. The topical composition of claim 1 , wherein the composition is an oil in water emulsion.

4. The topical composition of claim 1 , comprising:

a) about 1% to about 2.5% 5-fluorouracil;

b) about 0.005% calcipotriene;

c) about 3% diclofenac sodium;

d) about 12% to about 17% isopropyl myristate;

e) about 1% to about 3% cetyl alcohol;

f) about 1% to about 3% cetearyl alcohol;

g) about 1% to about 4% polysorbate 60;

h) about 1% to about 4% glyceryl stearate;

i) about 1% to about 4% PEG 100 stearate;

j) about 8% to about 12% propylene glycol;

k) about 2% to about 4% hydroxymethyl aminomethane;

l) about 1% to about 2% hydroxymethyl aminomethane HCl;

m) about 1% to about 3% benzyl alcohol; and

n) purified water.

5. A method of treating a skin lesion, comprising the steps of topically administering an effective amount of a topical composition to an affected area of a subject at least once daily for a period of time that reduces or eliminates the symptoms of that skin lesion in the subject, wherein the topical composition comprises:

a) about 0.5% to about 5% 5-fluorouracil or a salt or hydrate thereof;

b) about 0.001% to about 0.01% calcipotriene or a salt or hydrate thereof; and

c) about 1% to about 5% diclofenac or a salt or hydrate thereof.

6. The method of claim 5 , wherein the skin lesion is a cancerous or precancerous skin lesion.

7. The method of claim 6 , wherein the cancerous or precancerous skin lesion consists essentially of one or more of the following: basal cell carcinoma, superficial basal cell carcinoma, actinic keratosis, squamous cell carcinoma and squamous cell carcinoma in situ.

8. The method of claim 7 , wherein the period of time is 7 to 14 consecutive days.

9. A method of treating a precancerous or cancerous skin lesion comprising the steps of topically administering to an affected area an effective amount of a topical composition for a period of time that results in reduction or elimination of the skin condition, the topical composition comprising:

a) about 1% to about 2.5% 5-fluorouracil or a salt or hydrate thereof;

b) about 0.005% calcipotriene or a salt or hydrate thereof; and

c) about 3% diclofenac or a salt or hydrate thereof;

wherein the precancerous or cancerous skin lesion consists essentially of one or more of the following: basal cell carcinoma, superficial basal cell carcinoma, actinic keratosis, squamous cell carcinoma and squamous cell carcinoma in situ.

10. The method of claim 9 , wherein the period of time is at least once daily for at least 7 days.

11. The method of claim 7 , wherein the administration results in at least an 85% reduction in the respective lesion on the affected skin.

12. The method of claim 9 , wherein the administration results in at least an 85% reduction in the respective lesion on the affected skin.

13. The method of claim 5 , wherein the effective amount is about 0.1 to about 100 mg of the composition.

14. The topical composition of claim 1 , further comprising cetyl alcohol and isopropyl myristate.

15. The topical composition of claim 1 , further comprising isopropyl myristate, cetyl alcohol, polysorbate 60, glyceryl stearate, PEG 100 stearate, and cetearyl alcohol.