FINAL REPORT
PILOT EFFICACY EVALUATION OF A
SIZE REDUCING REGIMEN
Slenderizing Suit
Slenderizing Cream
Wraps
Sponsor
Sponsor Representative
Clinical Testing Facility
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Sponsor Code: |
G26 |
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ETC Panel No.: |
02055 |
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ETC Entry Nos.: |
8787.01-.03 |
Date of Final Report
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ETC Panel No.: 02055
ETC Entry Nos.: 8787.01.-03
SIGNATURE PAGE
PILOT EFFICACY EVALUATION OF A
SIZE REDUCING REGIMEN
Slenderizing Suit
Slenderizing Cream
Wraps
___________________________________ _______________________
Annemarie E. Hollenback, BA Date
Study Director
______________________________________ _______________________
Toni F. Miller, PhD, DABT, BCFE Date
Scientific Director
Principal Investigator
QUALITY ASSURANCE
STATEMENT
This study was conducted in accordance with the intent and purpose of Good Clinical Practice regulations described in CFR Title 21, Parts 50, 56 and 312 and/or the Declaration of Helsinki, as appropriate.
For purposes of this clinical study:
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Informed Consent was obtained. |
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Informed Consent was not obtained. |
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An IRB review was not required. |
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An IRB review was conducted and approval to conduct the proposed clinical research was granted. |
This study report has been reviewed to assure that it correctly describes the methods of testing and that the reported results accurately reflect the data obtained during the clinical study (ETC Panel No.: 02055; ETC Entry Nos.: 8787.01-.03).
_____________________________ _________________
Sherri L. Sayles, MS Date
Manager, Quality Assurance
ETC Panel No.: 02055
ETC Entry Nos.: 8787.01-.03
TABLE OF CONTENTS
1.0 OBJECTIVE.......................................................................................................... 1
2.0 SPONSOR................................................................................................................. 1
2.1 Sponsor Representative...................................................................................... 1
3.0 CLINICAL TESTING FACILITY............................................................................. 1
4.0 CLINICAL INVESTIGATORS................................................................................. 1
5.0 STUDY DATES......................................................................................................... 1
6.0 ETHICS...................................................................................................................... 2
6.1 Ethical Conduct of the Study............................................................................... 2
6.2 Subject Information and Consent........................................................................ 2
7.0 TEST MATERIAL...................................................................................................... 2
8.0 TEST SUBJECTS....................................................................................................... 2
9.0 STUDY DESIGN....................................................................................................... 3
9.1 Overall Study Design.......................................................................................... 3
9.2 Study Population................................................................................................ 3
9.2.1 Inclusion Criteria......................................................................................... 3
9.2.2 Exclusion Criteria........................................................................................ 3
9.3 Study Procedure................................................................................................ 4
9.3.1 Study Visit.................................................................................................. 4
9.3.2 Study Evaluation......................................................................................... 5
10.0 RESULTS AND DISCUSSION.............................................................................. 5
10.1 Evaluation of Measurements............................................................................. 5
11.0 CONCLUSIONS..................................................................................................... 5
APPENDIX 1 SUBJECT DEMOGRAPHICS
APPENDIX 2 INDIVIDUAL SCORES – SUBJECT MEASUREMENTS
Page: 1 of 5
ETC Panel No.: 02055
ETC Entry Nos.: 8787.01-.03
PILOT EFFICACY EVALUATION OF A
SIZE REDUCING REGIMEN
Slenderizing Suit
Slenderizing Cream
Wraps
1.0 OBJECTIVE
The objective of the study was to evaluate the efficacy of a size reducing regimen after 1 hour of use. Evaluations were conducted before application and after 1 hour of wear.
2.0 SPONSOR
Golden Touch
2.1 Sponsor Representative
3.0 CLINICAL TESTING FACILITY
The study was conducted by:
4.0 CLINICAL INVESTIGATORS
Study Director:
Annemarie E. Hollenback, BA
Principal Investigator: Toni F. Miller, PhD, DABT, BCFE
5.0 STUDY DATE
Page: 2 of 5
ETC Panel No.: 02055
ETC Entry Nos.: 8787.01-.03
6.0 ETHICS
6.1 Ethical Conduct of the Study
This study was conducted in accordance with the intent and purpose of Good Clinical Practice regulations described in Title 21 of the U.S. Code of Federal Regulations (CFR), the Declaration of Helsinki and/or Essex Testing Clinic (ETC) Standard Operating Procedures.
6.2 Subject Information and Consent
This study was conducted in compliance with CFR Title 21, Part 50 (Informed Consent of Human Subjects). Informed Consent was obtained from each subject in the study and documented in writing before participation in the study. A copy of the Informed Consent was provided to each subject.
7.0 TEST MATERIAL
The test articles used in this study were provided by:
Golden Touch
They were
received on
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Qty. |
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Entry
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Rec'd |
Test
Article I.D. |
Physical Description |
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8787.01 |
8 Suits |
Slenderizing Suit |
Black Vinyl Jacket and Pants |
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8787.02 |
8 Jars |
Slenderizing Cream |
Grey Cream |
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8787.03 |
50 Pieces |
Wraps |
Flesh Tone Elastic Cloth |
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8.0 TEST SUBJECTS
Eight (8) male and female subjects, ranging in age from 24 to 46 years, were empaneled for the test procedure.
Page: 3 of 5
ETC Panel No.: 02055
ETC Entry Nos.: 8787.01-.03
9.0 STUDY DESIGN
9.1 Overall Study Design
The study was a one-day study. A sufficient number of subjects meeting the inclusion criteria were enrolled so that 8 subjects completed the study.
9.2 Study Population
Subjects were enrolled in accordance with the following inclusion/exclusion criteria:
9.2.1 Inclusion Criteria
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Males and females between the ages of 18 to 69 years (inclusive), in general good health (no physical required). |
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Subjects free of any systemic or dermatologic disorder, including a known history of allergies or other medical conditions which, in the opinion of the Principal Investigator, could have interfered with the conduct of the study interpretation of results, or increased in the risk of adverse reactions. |
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Subjects who are between 20-40 pounds overweight according to the Metropolitan Life Insurance Scale. |
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Subjects who were able to understand and provide written Informed Consent. |
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Subjects who anticipated the ability to complete the course of the study and to comply with instructions. |
9.2.2 Exclusion Criteria
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Females who were pregnant or lactating or who anticipated becoming pregnant during the experimental period. |
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Subjects taking medications which might have interfered with the test results, including the use of steroidal/non-steroidal anti-inflammatory drugs or anti-histamines. |
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Subjects with acne or atopic dermatitis/eczema or psoriasis. |
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Subjects under treatment for asthma or diabetes. |
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Subjects with a known sensitivity or who have a history of sensitivity of cosmetics, personal care products or a sensitivity to vinyl or latex. |
Page: 4 of 5
ETC Panel No.: 02055
ETC Entry Nos.: 8787.01-.03
9.0 STUDY DESIGN (CONT’D)
9.3 Study Procedure
A sufficient number of test panelists meeting the entrance criteria were enrolled so that 8 subjects completed the test procedure. Subjects were instructed to wear a bathing suit or other appropriate clothing. The study was designed as a one-day trial in which the test regimen was used one time, according to Sponsor’s use instructions. Measurements of each thigh and abdomen were taken using a tape measure. Measurements were taken at baseline (pre-regimen application) and after 1 hour of wear.
9.3.1 Study Visit
Subjects reported to the Clinic for baseline measurements of the thighs and abdomen by a trained technician. The technician took measurements of each thigh and of the abdomen, marking the site with a skin marker to ensure that measurements were always taken from the same site. After baseline measurements, subjects applied the test regimen.
REGIMEN INSTRUCTIONS:
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The wraps were heated in water that was approximately 125 degrees. (Several wraps were placed into the water and allowed to soak and heat to the temperature of the water). |
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While wraps were heating, one of the rolled heated wraps was used to moisten the skin before applying the cream. The skin was moistened and the cream applied in steps. (For example, moisten and apply slenderizing cream to one leg then wrap, move on to the next leg, then abdomen). |
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The slenderizing cream was liberally applied in an upward direction, making sure to cover the entire area to be wrapped. |
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Wrapping the thighs: After applying the slenderizing cream, the thigh was wrapped in an upward motion. The wrap was applied firmly. The technician continued up the thigh, using as many wraps as needed, stopping just below the buttocks. The end of the wrap was tucked into the wrapped area to secure. |
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Wrapping the abdomen: Starting about 3 inches above the waistline, the abdomen was wrapped in a downward motion, using as many wraps as needed to wrap the waist and abdomen firmly. |
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When wrapping was completed, the subject put on a slenderizing suit and remained in the suit and wraps for 60 minutes. |
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After 60 minutes, the wraps were removed and the body remeasured, being careful to remeasure the same place that was measured prior to using slenderizing regimen. |
Page: 5 of 5
ETC Panel No.: 02055
ETC Entry Nos.: 8787.01-.03
9.0 STUDY DESIGN (CONT’D)
9.3.2 Study Evaluations
Evaluations of efficacy were based on a comparison of baseline vs. the 1-hour observation period.
10.0 RESULTS AND DISCUSSION
Eight (8/8) subjects successfully completed the test procedure. Subject Demographics are presented in Appendix 1.
10.1 Evaluations of Measurements
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Abdomen |
Right Thigh |
Left Thigh |
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Before |
After |
Before |
After |
Before |
After |
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Mean Measurement |
39.38” |
38.34” |
21.13” |
20.41” |
20.94” |
19.88” |
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Mean
Total Loss |
1.04” |
0.72” |
1.06” |
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When measurements taken at baseline were compared to those taken after 1 hour of wear, there was a mean loss of 1.04” on the abdomen, 0.72” on the right thigh and 1.06” on the left thigh. Individual loss at the abdomen ranged from 0.50” to 3.00”, 0.50” to 1.25” on the right thigh and 0.50” to 2” on the left thigh.
All subjects except one lost
inches on the abdomen and all subjects lost inches on their thighs. Individual losses ranged from 0.5 inches to
3 inches on the abdomen and 0.5 inches to 2 inches on the thighs. Individual
subject measurements are presented in Appendix 2.
11.0 CONCLUSIONS
At the conclusion of a 1-hour pilot clinical efficacy evaluation, Test Articles: Slenderizing Suit, Slenderizing Cream and Wraps were associated with a slight, but clinically significant size reduction on the abdomen and right and left thighs.
ETC Panel No.: 02055
ETC Entry Nos.: 8787.01-.03
APPENDIX 1
SUBJECT DEMOGRAPHICS
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Subject No. |
Initials |
Sex |
Age |
Race |
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1 |
JDA |
F |
31 |
HS |
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2 |
S-M |
F |
46 |
CE |
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3 |
PAG |
M |
24 |
CE |
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JSK |
M |
32 |
CE |
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AVW |
F |
32 |
BA |
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6 |
SPG |
M |
31 |
BA |
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7 |
JMC |
F |
42 |
CE |
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8 |
L-D |
F |
37 |
CE |
BA = Black (African American)
CE = Caucasian
HS = Hispanic
ETC Panel No.: 02055
ETC Entry Nos.: 8787.01-.03