U.S. Patent Science

P.E.T® Delivery
Technology

Permeation Enhancement Technology

P.E.T® (Permeation Enhancement Technology)

A patented drug-delivery system from SESHA Skin Therapy (Conrex Pharmaceuticals) that enhances ingredient absorption into deeper layers of skin without damaging the barrier. Safe, effective, and clinically backed.

How P.E.T® Works

PET™ is a drug delivery technology that works by solubilizing the active ingredient(s) within the polymeric matrices and temporarily modifying the permeability of the skin, thus enabling large molecules to pass between and through the skin cells of the stratum corneum, stratum lucidum, stratum granulosum and ultimately reaching the deeper layers of the skin (stratum spinosum, stratum basale) .

  • Considered GRAS (Generally Regarded as Safe), meaning it has a long history of safe use without ill effects and lacks irritation, contact sensitization, and phototoxicity
  • Holds a Drug Master File with the FDA
  • Patented and has patents pending in 15 international countries
  • Clinically proven to help active ingredients penetrate the stratum corneum

Penetration Comparison – Clinical Trial of PET™

Permeation evaluation of two topical preparations, one with Vitamin A palmitate, and the second with Vitamin E acetate . Both were combined with SESHA SKIN THERAPY’s PET™ delivery system. Permeation results were compared against placebo creams and were measured using Franz diffusion cells .

PARAMETERS:

Two cream preparations, each with and without PET™, applied topically to test subject.

RESULTS:

PET™ increased the retention of Vitamin A in the epidermis by 30% and in the dermis by 260%. PET™ demonstrated an increase of Vitamin E in the epidermis by 100% and in the dermis by 350%.

Pre-Clinical Studies

PET™ was evaluated by pre-clinical studies to test the efficacy of PET™ in drug formulations. Listed below are three of the pre-clinical studies done by our scientists to document the increased efficacy of drug permeation.

Diclofenac Acid

 Evaluation of the in vitro percutaneous (skin) permeation of 1% Diclofenac Acid gel prepared with PET™ delivery system. Permeation results are compared to an experimental control (1% Diclofenac Acid containing no PET™) and a commercially available preparation of 1% Diclofenac Acid (Voltaren® Emulgel).

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Clotrimazole

Evaluation of the in vitro percutaneous permeation enhancement of 1% clotrimazole preparation containing 4% PET™. Permeation results are compared to an experimental control (1% clotrimazole gel without PET™) and, a commercially available preparation of 1% clotrimazole (Lotrimin® AF topical solution).

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Testosterone

Evaluation of the in vitro percutaneous permeation enhancement of a testosterone gel containing 8% PET™. Permeation results are compared to an experimental control (testosterone gel without PET™).

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Clinical Studies

Conrex Pharmaceutical clinical studies were performed to test the efficacy of PET™ in developing the SESHA SKIN THERAPY skincare line. These studies show SESHA SKIN THERAPY is based on scientific proof of PET™ effectiveness in delivering pharmaceutical grade nutrients, cutting-edge antioxidants, superior quality botanicals, peptides, and other powerfully active ingredients to the deepest layers of the skin.

Study #1

Evaluation of the efficacy of SESHA SKIN THERAPY A.C.E. Cream with PET™ delivery system. Changes in the skin’s epidermal density, thickness, color and wrinkles depth were monitored using ballistometry, ultrasound B-mode scans, photographs, clinical assessments, silastic castings, and skin sample biopsies.

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study #2

Comparison of epidermal cell proliferation produced by SESHA SKIN THERAPY A.C.E. Cream containing PET™ nutrient delivery system with Retin-A Cream (0.025%) and Oil of Olay Original Beauty Fluid.

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Study #3

Research the effectiveness of Super C Serum and A.C.E. PLUS Cream in reducing fine lines and improving skin texture.

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Port Wine Stain Study

Clinical study shows PET™ could be an effective vehicle to deliver RPM in to the dermis in conjunction with laser therapy to inhibit Port Wine Staine (PWS).

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implications for Effective Port Wine Stain Study:

The advantage of topical application is that RPM could be delivered to the dermis while avoiding significant systemic drug absorption and associated side effects [41] . Two different topical RPM formulae were tested in this study. In both formulae, a skin penetration enhancer (PET™) was used. The results indicate that RPM can be effectively delivered through the stratum corneum using this enhancer.

Before/After: Subject used SESHA’s CLINICAL line for 3 months

Scientific Publications

Sesha Skin Therapy(Conrex Pharmaceutical) utilizes scientific books and publications to disseminate research findings and increase understanding of its patented technologies.

  1. Hsieh, Dean (editor)Controlled Release Systems: Fabrication Technology, Vol 1 & 2. CRC Press, 1988.
  2. Hsieh, Dean (editor)Drug Permeation Enhancement Theory and Applications. Vol. 62. Informa Health Care, 1994.

  1. Schrader S, Mills A, Scheperle M, Block JE. Improvement in sexual functioning and satisfaction in nonresponders to testosterone gel: clinical effectiveness in hypogonadal, HIV-positive males. Clin Cornerstone. 2005;7 Suppl 4:S26-31.
    PMID: 16651205 [PubMed – indexed for MEDLINE]
  2. Steidle C, Witt MA, Matrisciano J, Block JE. Sexual functioning and satisfaction in nonresponders to testosterone gel: Potential effectiveness of retreatment in hypogonadal males.
    Clin Cornerstone. 2005;7 Suppl 4:S20-5.
    PMID: 16651204 [PubMed – indexed for MEDLINE]
  3. McNicholas T, Ong T. Review of Testim gel.
    Expert Opin Pharmacother. 2006 Mar;7(4):477-84.
    PMID: 16503819 [PubMed – in process]
  4. Bouloux P. Testim 1% testosterone gel for the treatment of male hypogonadism.
    Clin Ther. 2005 Mar;27(3):286-98. Review.
    PMID: 15878382 [PubMed – indexed for MEDLINE]
  5. McNicholas TA, Dean JD, Mulder H, Carnegie C, Jones NA.
    A novel testosterone gel formulation normalizes androgen levels in hypogonadal men, with improvements in body composition and sexual function.
    BJU Int. 2003 Jan;91(1):69-74.
    PMID: 12614254 [PubMed – indexed for MEDLINE]
  6. Marbury T, Hamill E, Bachand R, Sebree T, Smith T.
    Evaluation of the pharmacokinetic profiles of the new testosterone topical gel formulation, Testim, compared to AndroGel.
    Biopharm Drug Dispos. 2003 Apr;24(3):115-20.
    PMID: 12673669 [PubMed – indexed for MEDLINE]

  1. Leary A, Stote R, Breedt H.J., O’brien J, Buckley B
    Diabetes Technology & Therapeutics Pharmacokinetics and Pharmacodynamics of Intranasal Insulin Administered to Healthy Subjects in Escalating Doses
    Diabetes Technology & Therapeutics. Feb 2005, Vol. 7, No. 1: 124-130
  2. Leary A, Stote R, Cussen K, O’brien J, Leary W, Buckley B
    Diabetes Technology & Therapeutics Pharmacokinetics and Pharmacodynamics of Intranasal Insulin Administered to Patients with Type 1 Diabetes: A Preliminary Study
    Diabetes Technology & Therapeutics. Feb 2006, Vol. 8, No. 1: 81-88

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