AcnEase® Clinical Study

REVIEW OF CLINICAL STUDIES

Clinical Study Outline for Chinese NDA

Site: The Clinical Study was performed at Xiyuan Hospital of China: Academy of Traditional Chinese Medicine, Beijing PRC in 1999.

Patients: 30 individuals ages (11 male 19 female) age 18-37, average course of disease 3-5 years

Treatment: AcnEase® 8 tablets/day for 30 days

Efficacy: Decrease in the number and severity of skin lesions, white heads and black heads. Serum testosterone and facial corynebacteria determinations were performed.

Safety: Clinical Chemistry, Hematology, Urine Analysis and Adverse Events

Results: Over 80 % Response Rate Following 1 month of Treatment

Methods: Acne was measured before and after treatment. Severe acne was rated a score of 3, medium acne a score of 2 and light acne assigned a score of 1. One measure of efficacy was measured as follows: for every improvement in the grade of severity of 2 units, a remarkably effective rating was assigned, an improvement in score of 1 unit was classified as effective. For example if an individual was rated a score of 3 and after therapy was reduced to a score of 1 this was considered remarkably effective.

For quantitative measurements each acne lesion was assigned a score (1-3) and the total score for each participant recorded before and after treatment. For this case if the total score decreased by >70% the response was rated remarkably effective, if the accumulated score decreased by >30% the response was ranked effective and less then 30% decrease in score was rated ineffective.

Results:

Table 1

Change in the Mean Number of Acne Lesions

Lesion Type # Of Cases Prior to Treatment After Treatment
Inflam. Papula 24 22.2 10.6
White Head 26 14.6 3.96
Black Head 21 23.1 10.1

In this assessment of efficacy AcnEase® caused a greater then 50% reduction in the number of each type of acne lesion.

Table 2

Change in Accumulated Acne Scores

Lesion Type # Of Cases Prior to Treatment After Treatment
Inflam. Papula 30 30.3 10.7
White Head 30 21.4 4.7
Black Head 30 15.8 5.2

The decrease in the accumulated score, which takes into account the severity, and extent of acne was dramatic. Within 1 month the accumulated scores for white heads and black heads decreased by approximately 75% and 65% respectively. The number and severity of inflammatory papules also decreased by over 65%.

Evaluation of the level of effectiveness as judged by the extent of decrease observed for each patient revealed that 7/30 patients were scored as remarkably effective, 17/30 were judged to be effective with the remaining 6/30 judged not effective, yielding an overall effectiveness rating of 80%.

Analysis of the level of corynebacteria associated with the acne lesions was reduced nearly 50% but the small sample size did not yield statistical significance. The levels of serum testosterone did not change following treatment.

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