Clinical Studies.

  1. “The efficacy of SheaFlex70™ on Rheumatoid Arthritis – Full Trial;” Dr. K, University Hospital, Japan; 2010.
    Study in development.
  2. “The efficacy of SheaFlex70™ on Rheumatoid Arthritis – Pilot Study;” Dr. K, University Hospital, Japan; 2009.
    Pilot trial, 3 month duration, positive trend required and confirmed.
  3. “SheaFlex70™ and Glucosamine Synergism in Osteo-Arthritis” Duke University, Durham, NC, USA; 2009.
    Study in development. 10-month, guinea pig OA animal model. 4 study arms: placebo, FlexNow®, Glucosamine and FlexNow + Glucosamine. Outcome measures: inflammatory, bone and cartilage biomarkers together with histological examination.
  4. “Safety and efficacy on Japanese Osteo-Arthritis Patients;” Dr. K, University Hospital, Japan; 2009.
    Safety parameters, plus pain and stiffness measures. Results pending.
  5. “Meta Analysis of BSPPEMS + GIBPEMS;” Tonny Jorgensen, CSO; BSP Pharma A/S; 2009.
    Preliminary results show the pain level in the glucosamine group is 73% higher than in the FlexNow® group.
  6. “Randomized placebo controlled trial on the safety and efficacy of SheaFlex70 in Osteo-Arthritis,” Dr. Philip Cheras; ACCMER, University of Queensland, Brisbane, Australia; 2007.
    Substantial and statistically significant anti-inflammatory effect in humans, plus chondroprotective and bone remodelling effects.
  7. “GIB: Evaluation of Glucosamine Sulphate and Ibuprofen versus Placebo,” Dr. Allan Rosetzsky; Klifo, A/S, Copenhagen, Denmark; 2005.
    Treatments revealed no significant effect except from Glucosamine Sulphate which had a higher VAS pain score compared to placebo, which is the opposite of what was expected.
  8. “Evaluation of The Efficacy and Safety of a Sheabutter Extract [SheaFlex70™] on Cold Sores (Acute and Prophylactic);” Dr. Philip A. Cheras; ACCMER, Brisbane, Australia; 2005.
    The product was able to significantly reduce the reoccurrence of cold sores.
  9. “A Randomized Double-Blinded Placebo Controlled Study of [SheaFlex70™] for the Treatment of Patients With Moderate To Severe Plaque Psoriasis;” Dr. Frederic Boudjema; Pharmascan, Villeurbanne, France; 2004.
    Post hoc data analysis revealed that the subgroup with initial PASI>20 achieved a statistical reduction of >30% after 3 months.
  10. “A Double-Blind Randomized Placebo Controlled Parallel Group Study Demonstrates Analgesic Effects of Sheanut Oil Extract [SheaFlex70™] in Exercise Induced Muscle Tenderness (BSPPEMS);” Lars Arendt-Nielsen, DmedSci, Ph.D.; Aalborg University, Denmark; Journal of Musculoskeletal Pain, Vol. 17, Issue 1, February 2009, pages 8-14; 2003.
    Study found a significant 49% pain reduction in the active group compared to placebo. Product was found to be safe.
  11. “Mouse Micronucleus;” Karin Kaaber, DVM; ScanTox; 2003.
    No genotoxicity observed.
  12. “Ames Test;” Karin Kaaber, DVM; ScanTox, Denmark; 2003.
    No genotoxicity observed.
  13. “Acute Oral Toxicity;“ Karin Kaaber, DVM; ScanTox, Denmark, 2003.
    LD50 >2000mg/kg
  14. “Ulcerogenic Effect;“ Karin Damm Jorgensen, DVM, Study Director; BioAdvice, Vedbaek, Denmark; 2003.
    his ulcerogenic safety study confirmed that SheaFlex70 caused no gastrointestinal lesions in contrast to Ibuprofen, which was used as the control.
  15. “Determination of Anti-Inflammatory Properties of Topical Formulations Containing Shea Butter Extract on Lesional Skin of Patients With Atopic Dermatitis;” J. Gassmüller, MD; BioSkin Institute for Dermatological Research, Hamburg, Germany; 2003.
  16. “Evaluation of the irritating and sensitizing potential by repeated 48-hours epicutaneous applications under patch-tests (Marzulli & Maibach method);” Dr. Yvette Weltert, dermatologist; Pharmascan, Villeurbanne, France; 2003.
    The product can be considered hypo allergenic. The product was not associated with any clinically significant photo allergenic response.
  17. “Cutaneous Irritancy by MTT Assay on Human Skin Biopsies;” Alain Deguercy; Laboratoire Dermscan, Villeurbanne, France; 2003.
    The product is non-irritant in this model.
  18. “Evaluation of Ocular Irritancy. (HET-CAM Assay);” Alain Deguercy; Laboratoire Dermscan, Villeurbanne, France; 2003.
    The product is non-irritant in this model.
  19. “Topical Safety Study; Photosensibility;” Dr. Marlena Nowakowska, MD; Group Dermscan, France; 2003.
    The product is non-photosensitising.
  20. “Evaluation of The Acute Cutaneous Tolerance. 48h Occlusive Patch Test Under Dermatological Control;” Dr. Yvette Weltert; Palmer Research-Dermscan Group; St. Etienne, France; 2003.
    Product is non-irritant.
  21. “Screening of Anti-Inflammatory Effect in The Repeated Oxazolone Mouse Ear Oedema Assay;” Morten Sloth Weidner, Ph.D.; Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark; 2003.
    This model simulates chronic inflammatory conditions. When administered systemically, the product demonstrated a dose dependent anti-inflammatory response. The highest concentration was approximately twice the response as the positive control 10/mg methyl prednisolone.
  22. “Screening For Anti-Iinflammatory Effect in The TPA Subchronic Mouse Ear Oedema Assay;” Hans Christian Wulf, Dr. Med.; Morten Sloth Weidner, Ph.D.; Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark; 2003.
    This model simulates chronic inflammatory conditions. The product had a statistical significant inhibitory effect on repeated TPA induced oedema (very strong inflammation) (x4) formulation optimisation tests.
  23. “Screening of Anti-Iinflammatory Effect in The Oxazolone Mouse Ear Oedema Assay;” Hans Christian Wulf, Dr. Med.; Morten Sloth Weidner, Ph.D.; Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark; 2003.
    Confirmed topical anti-inflammatory effect as well as a significant dose dependent systemic anti-inflammatory effect equal in the highest dose to 30mg/kg methyl prednisolone.
  24. “Screening For Anti-inflammatory Effect in The Arachidonic Acid Mouse Ear Edema Assay;” Hans Christian Wolf, Dr. Med.; Morten Sloth Weidner, Ph.D.; Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark; 2003.
    Product did not reach significance in this model. Possible due to an alternative mode of action.
  25. “Collagen II Rat Arthritis Assay;” Karin Damm Jorgensen, DVM, Study Director; BioAdvice, Vedbaek, Denmark; 2003.
    This chronic joint inflammation model confirmed the alleviation of joint specific chronic inflammation to a level equal to dexamethasone.
  26. “Carrageenin Induced Rat Paw Oedema assay;” Karin Damm Jorgensen, DVM, Study Director; BioAdvice, Vedbaek, Denmark; 2002.
    This acute inflammatory model confirmed the dose dependent anti-inflammatory effect of BSP201. The effect of a daily dose was comparable to a moderate dose of Ibuprofen. (x3)
  27. “The Effect of Sheanut Oil on Serum Lipids and Lipoproteins in Normocholesterolemic and Mildly Hypercholesterolemic Humans;” Eric Berg Schmidt; Department of Medicine, Hjorring/Bronderslev Hospital; Journal of the American College of Cardiology, Abstract 2894, May 1, 2002, Vol. 39, Issue 9, Suppl. B; 2001.
    LDL cholesterol decreased 8% in active group. Product was found to be safe.
  28. “Screening For Anti-Inflammatory Effect in The Mouse Ear Oedema Assay (TPA);” Karin Damm Jorgensen, DVM; Panum Institute, Copenhagen, Denmark; 2001.
    All versions of the product demonstrated a statistically significant dose dependent anti-inflammatory effect. A dosage of 1mg demonstrated the same inhibition as 0.2mg hydrocortisone-17-butyrate. (x2)
  29. “TNF-á/IL-6 Study;” Morten Weidner; Astion A/S, Copenhagen, Denmark; 2001.
    This test showed a strong reduction of pro-inflammatory cytokines TNF-á and IL-6 equal to the effect obtain with a comparable dosage of methyl prednisolone. (x2)
  30. “NF-êB Mechanistic Study;” PanLabs Taiwan Ltd., Taipei, Taiwan; 2000.
    FlexNow® was shown to inhibit NF-êB dependent transcription response.
  31. “Receptor Binding;” PanLabs Taiwan Ltd., Taipei, Taiwan; 2000.
    Confirmed safety. FlexNow did not bind to the glucocorticoid receptors suggesting a different mode of action and side effect profile than steroids.
  32. “Evaluation of Anti-Viral Effect;” James H. Gilbert, Ph.D., MDS; PanLabs Biosafety, Bothell, WA, USA; 1999.
    Product demonstrated antiviral activity against herpes simplex and to a lesser extent Influenza A.

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