Imedeen Prime RenewalTM In-Vivo Study
Stephens & Associates Inc. Dallas, TX, USA
October 2003 – April 2004

From October 2003 through April 2004, Thomas J. Stephens & Associates, Inc. conducted an in-vivo study on the efficacy of Imedeen Prime Renewal. The efficacy study was double-blind, placebo-controlled and ran over a six month period.

Female participants were between the ages of 45-65 and were 1 to 5 years post menopausal. Eighty participants completed the study: 38 participants received Imedeen Prime Renewal and 42 participants received a placebo.

The supplementation period was 6 months with the intake of 2 tablets in the morning and 2 tablets in the evening of Imedeen Prime Renewal or placebo test material.

Methods and Results
Method: Ultrasound scanning was used to measure skin density. Increases in density measurements describe improvement in dermal structure. At baseline, after 3 months and again after 6 months of use of Imedeen Prime Renewal, a scan of each subject’s crow’s feet area was taken.

Results: The ultrasound scans show an increased density compared to baseline, visualized by the increasing concentration of reflective elements, as seen in the scanning illustrations below.

Clinical photos
Method: Digital photos of the participants’ faces were taken at baseline, after 3 months and again after 6 months using a standardized setup. Baseline clinical photos were used as the basis for the clinical grading of the participants, where the investigator performed a blind evaluation of several skin-aging parameters in 3 months and again after 6 months of Imedeen Prime Renewal usage.

Results: After 3 months and again after 6 months’ treatment, the group taking the Imedeen Prime Renewal showed statistically significant improvement compared to the placebo group in wrinkles on forehead and in the eye area, as well as in hyperpigmentation and improvement in the overall appearance of the facial skin.

Clinical grading
Method: The clinical signs of aged skin in women post menopause were assessed by the investigator for several parameters - for the skin on the face, on the hands and the décolletage. The investigator performed a blind evaluation of the subjects at baseline, after 3 months and again after 6 months of Imedeen Prime Renewal use.

Results: After 3 months and again after 6 months treatment, the group taking the Imedeen Prime Renewal showed statistically significant improvements compared to the placebo group.

Consumer Interviews
After 6 months of Imedeen Prime Renewal usage, the subjects were interviewed about their experience with the product.

Sixty-six percent of the women taking Imedeen Prime Renewal expressed that after using the product, they felt that the quality of the skin of their face and hands had really improved, that their skin felt more moist, soft and supple, and that their complexion looked nicer, more even and more radiant.

Conclusion
Evaluation of the results from the study show that compared to the placebo, Imedeen Prime Renewal used for 3 to 6 months visibly improves the appearance and condition of the skin significantly in women post menopause by:

• Improving the dermal density of the skin
• Creating firmer skin
• Reducing visibility of fine lines and wrinkles
• Reducing visibility of hyperpigmentation
• Improving the appearance of skin on the hands and on the décolletage