STUDY OBJECTIVE:
To evaluate the effectiveness in weight reduction of the Patch in a sustained controlled release patch formula, in a subjects having exogenous obesity.
 
DOSAGE:
One patch daily
 
STUDY DESIGN:
To determine the average amount of body weight loss over a sixty day period for both men and women who were highly motivated and agreeing to follow a well balanced diet while wearing one patch per day. The subjects were evaluated for effectiveness at one week intervals for the first thirty days and then ten day intervals for the next thirty days.
 
SELECTION CRITERIA:
100 male and female subjects between the ages of 19 - 67 years of age, whose body weight was between 17 - 163 pounds in excess of normal as determined from the Metropolitan Life Insurance Co. body weight charts, were admitted to the study.
 
STUDY VARABLES:
Primary - body weight was recorded by the investigator and evaluated the first and last ''weight in'' for each participant in the program. Secondary - each participant recorded their own progress on the instruction sheets that accompanied the proposed balanced diet.
 
STATISTICAL METHODS:
All participants had attested to trying many and varied diets and weight loss programs over a period of one or more years. Approximately 25% expressed skepticism about the effectiveness of a ''patch'' to lose weight.

 

RESULTS:	WOMEN	MEN
7 days	3.04%	2.35%
14 days	4.87%	4.18%
21 days	6.35%	5.92%
30 days	7.92%	7.79%
40 days	9.66%	8.95%
50 days	11.71%	11.54%
60 days	13.59%	12.46%
Age Range (in years)	19 to 64	22 to 67
Average age	37	35
Over Weight Range in Pounds	17 to 163 (54 lbs)	21 to 148 (52 lbs)

EFFECTIVENESS : At the first post-baseline evaluation (after 7 days of wearing the patch) the overall mean weight loss for the participants was 2.69% of baseline. Each subsequent post-baseline evaluation reported by the participants produced a constant decrease in their baseline weight. At the end of 30 days the mean baseline weight loss for the participants was 7.85% body weight. At the conclusion of the 60 day period the investigator reports a mean weight loss of all participants of 13.02% of baseline average weight.
 
SAFETY : 
Side effects experienced by only 2 persons consisted of mild skin irritation when wearing the patch on the inside of the upper arm. The same subjects did not repeat this side effect after alternating the placement of the patch. No other side effects were reported.
 
CONCLUSIONS : 
The efficacy of the Weight Control Patch was 100%. All participants lost weight while wearing the patch for the full 60 days. Those with the least amount of body weight loss, continued to wear the patch to maintain their desired body weight. The most significant weight loss was 71 pounds by one highly motivated individual who followed the ''letter of the plan'', ate properly, consumed 8, 8-ounce glasses of water per day, walked daily and participated in a structured and supervised exercise program.