Laser Lipo Ltd. Strawberry and Strawberry & Cream. Clinical Trial Protocol
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1 Laser Lipo Ltd K (k) Strawberry and Strawberry & Cream Clinical Trial Protocol Conducted at: The Heath House Clinic, Crockham Hill, Edenbridge, Kent, UK. Laser Lipo Ltd. K (k) Page No. of 11 pages.
2 Index of contents. Index: 1. The "Heath House Clinic" Page Data consolidation and outcome Page Statistical analysis Page Conclusion Page 11. Laser Lipo Ltd. K (k) Page No. 2 of 11 pages.
3 1. The Heath House Clinic The "Heath House Clinic" is an operational beauty clinic. It is located on the first floor of the building. The clinic is a 2 roomed treatment salon that offers Laser Class 4 hair removal, laser inch loss treatments and a range of beauty treatments. The clinic compliments Laser Lipo Ltd as a perfect test site and location for training. The staff involved are all qualified to NVQ level III. Laser Lipo Ltd. K (k) Page No. 3 of 11 pages.
4 2. Treatment Consolidated Data Heath House Clinic Double Blind Clinical Study - Strawberry Inch Loss- July/Aug Confidential. Laser Lipo Ltd. K (k) Page No. 4 of 11 pages.
5 2. Treatment Data and Charts Chart displaying the inch loss results for all subjects LL KD JBCMRNH JS AB LG CM MH PO SP MC SH WH LJ NM EB LG TP LB NC ZC LE FL SH JWACOVMCRM CG AF CW CMBSJS The red line above shows the 1.6in success criteria point. The only treated subject to not reach this level was MC (No. 22). Subject No.: Initials: Treatment type: Waist reduction: (In) 17 LL KD JB CMR NH JS AB LG CM MH PO SP MC SH WH LJ NM EB LG TP LB NC ZC LE FL SH JW ACO VMC RM CG AF CW CM BSJS 5.6 Laser Lipo Ltd. K (k) Page No. 5 of 11 pages.
6 2. Treatment Data and Charts Chart displays inch loss achieved with only the treated subjects. Of the treated subjects, one failed to pass the success criteria of 1.6in (4cm). The average inch loss of all 22 treated subjects was 3.7in (9.4cm). Inch loss results for all '' Subjects. Subject No.: Initials: Treatment type: Waist reduction: (In) 22 MC WH LJ NM EB LG TP LB NC ZC LE FL SH JW ACO VMC RM CG AF CW CM BSJS 5.6 Laser Lipo Ltd. K (k) Page No. 6 of 11 pages.
7 2. Treatment Data and Charts Not one of the placebo subjects achieved the success criteria of 1.6in (cm) and in fact 3 of the placebo subjects gained in circumference, despite carrying out the cardiovascular exercise. subjects: Subject Intials: Inch Loss: LL KD JB CMR 0.00 NH 0.28 JS 0.71 AB 0.79 LG 0.94 CM 0.98 MH 1.06 PO 1.06 SP 1.14 SH 1.30 Laser Lipo Ltd. K (k) Page No. 7 of 11 pages.
8 2. Treatment Data and Charts With an age range from 20 to 76 years the study group covers a huge spectrum. The results show that age is not a consideration regarding the achieved results. Ages: Subject Initials: Inch Loss: Age: LL KD JB CMR 0 54 NH JS AB LG CM MH PO SP SH Ages: Subject Initials: Inch Loss: Age: EB ACO NM ZC MC CW TP LB LG SH CG LJ VMC BSJS WH CM AF NC RM FL JW LE Laser Lipo Ltd. K (k) Page No. 8 of 11 pages.
9 2. Treatment Data and Charts There does not appear to be any trend relating to the results and the subject s gender. Gender: Subject Initials: Gender: Inch Loss: WH F 2.36 LJ F 2.56 NM F 2.87 EB F 3.15 LG F 3.27 TP F 3.31 LB F 3.31 NC F 3.70 ZC F 3.70 LE F 3.74 SH F 3.94 JW F 3.98 ACO F 4.13 VMC F 4.13 CG F 4.37 AF F 4.49 CW F 4.49 CM F 5.08 BSJS F 5.63 FL F 3.78 RM M 4.29 MC M 1.22 Laser Lipo Ltd. K (k) Page No. 9 of 11 pages.
10 3. Statistical analysis. To test for randomisation bias, the Fishers Exact Test (2-sided) was used. The p-value was determined to be <0.05, assuming a null hypothesis. Randomisation is determined to be better than 95%. Therefore randomisation was achieved. Limit on Control Success for Statistical Significance (Fisher s Exact, 2-sided) for Given Sample Size and Success Rate among the # # s Number of among Allowable among s Number of among s (>95%) 5 0 (ACTUAL) (90%) 5 (EXAMPLE) (80%) 4 (EXAMPLE) (70%) 3 (EXAMPLE) CELL MAP: A C B D loss > 1.6" loss < 1.6" margins RESULTS: A&B! C&D! margins A&C! B&D! N! E+35 Formula: E E+61 p-value <0.05 Probability: E-08 Laser Lipo Ltd. K (k) Page No. 10 of 11 pages.
11 4. Conclusions. The criteria for success in this study was that at least 80% of the treated study subjects would achieve a lost of at least 1.6 inches around their waist (measured at the iliac crest, parallel to the floor) over 8 treatments in a 4 week period, while no more than 40% of the placebo group would achieve at least 1.6 inches around the waist. The original plan was to use 20 participants for the treated group and 10 participants for the placebo (sham) group. In order to ensure that these numbers of participants were still active at the end of the 4-week study, a total of 35 participants were recruited. 22 of participants were randomly chosen to be members of the treated group and 13 participants were chosen to be members of the placebo group. At the end of the 4 weeks, only 32 persons completed the study; 21 in the treated group and 11 in the placebo group. Rather than randomly reducing the number of participants from 32 to 30, the actual number of participants who finished all eight treatments in the 4 week period were used to consider success or failure of the study. In the table shown below, 21 participants in the treated group completed all treatments. Of the 21 treated, 20 lost more than 1.6 inches around the waist and 1 did not. Therefore, 95.24% of the treated group lost >1.6 inches around the waist. Of the 11 participants in the placebo group, no one lost 1.6 inches or more from around the waist. # # s Number of among Allowable among s Number of among s (>95%) 5 0 Based on the data gathered, within all constraints set forth in the prospective clinical study protocol, the Laser Lipo Strawberry and Cream laser system has fulfilled the criteria for success within the parameters of this study. In addition, it is important to note that there were no adverse reactions experienced by any of the placebo or treated subjects. Laser Lipo Ltd. K (k) Page No. 11 of 11 pages.
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