IMEDEEN TAN OPTIMIZER

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IMEDEEN TIME PERFECTION IN-VIVO STUDY
Thomas J. Stephens Associates, Inc., Dallas,
Texas, USA Investigator Monya L. Sigler, Ph.D.
Conducted from Dec. 2002 to March 2003
STUDY OBJECTIVE Assessment of Time Perfections
effect on skin with signs of ageing
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• STUDY DESIGN
• Double-blind, placebo-controlled
• 12 weeks efficacy study
• 2 tablets a day
• 74 healthy women completed the study
• 36 using Imedeen Time Perfection
• 38 using Placebo
• Objective and subjective assessments
• INCLUSION CRITERIA
• 35 - 60 years
• Skin type I - III (Fitzpatrick)
• Moderate to advanced signs of ageing (Glogau
  II-III)
• Presence of moderate fine lines and wrinkles

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OBJECTIVE ASSESSMENTS

• Clinical grading by study Investigator
• Skin ageing parameters assessed
• Fine lines/wrinkles
• Hyper pigmentation/age spots
• Pore size
• Visual and Tactile laxity
• Dull/matte appearance
• Visual and Tactile roughness
• Under eye dark circles and bags
• Telangiectasia
• Skin dryness
• Blotchiness
• Global assessment

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OBJECTIVE ASSESSMENTS

• NOVA Dermal Phase Meter (NOVA Technologies)
• Parameter Skin Hydration
• Measurement is proportional to the dielectric
  constant of the surface layers of the skin and
  increases as the skin becomes more hydrated.
• Duplicate NOVA DPM measurements were taken on the
  center of each subjects qualified cheek
  (midpoint between the lines connecting the
  lateral edge of the eye and the bottom of the
  nose).

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OBJECTIVE ASSESSMENTS
Ultrasound Scanning (DUB 20, Taberna, Pro
Medicum, AG) Parameter Skin Density
A standard 20 MHz transducer with a focal
distance of 15 mm and a 40dB amplification.
Scanning of each subjects qualified cheek or
on the middle of the forehead.
Analysis of ultrasound images include an analysis
of dermal density
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STUDY SCHEDULE
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RESULTS - Clinical grading
All the evaluated parameters for ITP showed more
improvement than placebo. p 0.0047 for all
variables being improved (chi square test)
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RESULTS - NOVA Dermal Phase Meter
Conclusion A significant improvement in
moisturization after 12 weeks use was found in
the Imedeen Time Perfection supplemented group,
compared to the placebo group. Significance (p
0,0464)
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RESULTS - Ultrasound Scanning
Conclusion A significant improvement in dermal
density after 12 weeks use was found in the
Imedeen Time Perfection supplemented group,
compared to the placebo group. Significance p
0,0001
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RESULTS Ultrasound Scanning (DUB 20)
The image after 12 weeks show increased density
compared to baseline. The reflective elements in
skin (collagen and elastin) are visualized by the
green, blue and red colors in the scan. After 12
weeks, the density of dermis showed significantly
greater improvement for the Imedeen Time
Perfection group than the placebo group.
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STUDY CONCLUSION When used for twelve weeks,
Imedeen Time Perfection proved to be effective
in improving the appearance and condition of skin
with signs of ageing.
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Two tablets of Imedeen Time Perfection used daily
for 3 months

• Improves the moisture content of the skin
• Improves the structure and density of the dermal
  layer of the skin
• Decreases the visibility of fine lines and
  wrinkles
• Decreases visibility of hyper pigmentation and
  age spots
• Reduces pore size
• Decreases laxity, improving firmness of the skin
• Decreases a dull, matte appearance, giving the
  skin glow
• Decreases skin roughness/improves smoothness
• Decreases under-eye dark circles and bags
• Decreases Telangiectasia / visible capillaries
• Decreases blotchiness
• Improves overall assessment of the facial skin
• Improves the smoothness and dryness of the body
  skin

Self-Assessment The women using Imedeen Time
Perfection experienced improvements in face and
body skin with respect to structure, dryness,
softness, texture an overall improvement.
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Publication of results
European Academy of Dermatology and Venereology
October 2003 Abstract has been accepted for an
oral presentation. Presentation by Dr. Sigler
concerning results from the subjective
assessments obtained in the study. The
presentation takes place at EADV in Barcelona
October 18th at 0905 in room 9. Society of
Cosmetic Chemists December 2003 Poster has
been submitted. The Annual Scientific Meeting,
December 4th and 5th , 2003. The New York Hilton
Towers Hotel, New York City