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Claims for Patent: 4,322,438

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Claims for Patent: 4,322,438

Title: Method for the use of orally administered 13-cis-retinoic acid in the treatment of acne
Abstract:In a method of alleviating nodulocystic and conglobate acne in humans by the oral administration of 13-cis-retinoic acid, the improvement comprising: administering the 13-cis-retinoic acid in a high dosage of from 1.0 to 2.0 mg/kg/day for from 2 to 4 weeks; and reducing the amount of 13-cis-retinoic acid to a low dosage of from 0.25 to 0.5 mg/kg/day for a period of from 12 to 14 weeks, so that the total treatment period is about 16 weeks.
Inventor(s): Peck; Gary L. (Silver Spring, MD)
Assignee: United States of America (Washington, DC)
Application Number:06/175,594
Patent Claims: 1. In a method of alleviating nodulocystic and conglobate acne in humans by the oral administration of 13-cis-retinoic acid, the improvement comprising:

(a) administering 13-cis-retinoic acid in a high dosage of from about 1.0 to about 2.0 milligrams per kilogram of body weight daily for a first period of from about 2 to about 4 weeks; and

(b) reducing the amount of 13-cis-retinoic acid to a low dosage of from about 0.25 to about 0.5 milligrams per kilogram of body weight daily for a second period of from about 12 to about 14 weeks, for those patients whose acne has not been substantially improved at the end of the first period as measured by the percentage reduction in cysts, so that the total treatment period is about 16 weeks.

2. The improved method of claim 1 wherein the high dosage is administered for about 2 weeks.

3. The improved method of claim 1 wherein the high dosage is administered for about 4 weeks.

4. The improved method of claim 2 or 3 wherein at least 60% of a patient's acne lesions appear on the face and wherein the high dosage is about 1.0 milligrams per kilogram of body weight daily and the low dosage is about 0.25 milligrams per kilogram of body weight daily.

5. The improved method of claim 2 or 3 wherein at least 60% of a patient's acne lesions appear on the trunk and wherein the high dosage is about 2.0 milligrams per kilogram of body weight daily and the low dosage is about 0.5 milligrams per kilogram of body weight daily.

6. In a method of alleviating nodulocystic and conglobate acne in humans by the oral administration of 13-cis-retinoic acid, the improvement comprising:

(a) administering 13-cis-retinoic acid in a high dosage of about 2.0 milligrams per kilogram of body weight daily for a first period of about 4 weeks;

(b) reducing the amount of 13-cis-retinoic acid to a low dosage of about 0.5 milligrams per kilogram of body weight daily for a second period of about 12 weeks, for those patients whose acne has not been substantially improved at the end of the first period as measured by the percentage reduction in cysts, so that the total treatment period is about 16 weeks.

7. The improved method of claim 1 or 6 wherein the regimen comprising steps (a) and (b) is repeated up to three times.

8. The improved method of claim 1 or 6 wherein the regimen comprising steps (a) and (b) is repeated upon each reoccurrence of the acne.
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