Clinical Studies
The creators of NeoStrata®, Drs. Van Scott and Yu, are internationally recognized as visionaries and leaders in the field of cosmetic dermatology. They are the creators and original patent-holders of the first glycolic peel and discovered the rejuvenating power of Alpha Hydroxy and Polyhydroxy Acids (AHA/PHAs), revolutionizing the treatment of aging skin. They have been recognized with the most prestigious accolades in the field:
  • the first Gold Medal given by the International Academy of Cosmetic Dermatology
  • the Master of Dermatology Award from the American Academy of Dermatology
  • the first Head of the Dermatology Branch of the National Institutes of Health

Gluconolactone Improves Signs of Photoaging Among Women With Sensitive Skin

A gluconolactone PHA-containing regimen including the Exuviance Purifying Cleansing Gel, Soothing Toning Lotion, Multi-Protective Day Fluid SPF 15 (morning application) and Evening Restorative Complex (evening application) was assessed on 25 women with sensitive skin and moderate to advanced photoaging. All parameters of photoaging were significantly improved after six and twelve weeks of twice daily use, including firmness, sallowness, fine lines, wrinkles, roughness, hyperpigmentation and pore size (p<0.05). Silicone replicas revealed a reduction in the appearance of fine lines and wrinkles by over 30% in twelve weeks. Significant improvements were also observed in skin dryness and scaling (p<0.05). The products were well tolerated by the sensitive skin panelists and any preexisting irritation was improved during treatment, including erythema, tightness and tingling (p<0.05).

References
Bernstein EF, Green BA, Edison B, Wildnauer RH. Poly Hydroxy Acids (PHAs): Clinical Uses for the Next Generation of Hydroxy Acids. Skin & Aging Sep. 2001 Supplement.

Mean Relative % Improvement
(Compared to Baseline)

 


Key Advantages and Claim Support of Bionic and Polyhydroxy Acids and Lactones
The polyhydroxy acids (PHAs) including the bionic acids (BHAs) represent the next generation of alpha-hydroxyacids (AHAs) for use in cosmetic and dermatologic skin care. Structurally similar to traditional AHAs, the polyhydroxy acids (gluconolactone) and bionic acids (lactobionic acid) provide anti-aging and skin smoothing effects comparable to AHAs, while offering several therapeutic advantages. PHAs are less irritating to skin as compared to AHAs, and cause less stinging and burning. PHA compatibility with clinically sensitive skin types has previously been demonstrated in patients diagnosed with atopic dermatitis and rosacea. PHAs also enhance skin barrier efficiency. These molecules also function as humectants and moisturizers, as well as provide antioxidant-chelation effects due to their polyhydroxy structure. Importantly, tested PHAs do not increase the skin’s potential for sun sensitivity and provide free radical scavenging effects.

PHAs Provide These Key Benefits:

1. Provide Anti-aging Benefits Comparable to AHAs: The PHA acids and lactones have all the known effectiveness of the AHAs in alleviating the signs of dermatological photoaging, while being very gentle. PHA formulations have exhibited strong anti-aging effects including marked improvements in skin clarity (260%, p<0.05) and notable skin plumping (thickening) effects (9.7%, p<0.05). Anti-aging effects have been demonstrated histologically including: increased GAGs, increased viable epidermal thickness and reduced MMP activity. Benefits have been observed on various ethnic skin types including African-American, Asian, Hispanic and Caucasian.

  • Green BA, Edison BL, Sigler ML. Antiaging effects of topical lactobionic acid: results of a controlled usage study. Cosmet Dermatol 2008;21(2):76-82.
  • Green BA, Edison BL, Wildnauer RH. Lactobionic acid, a bionic acid enhances skin clarity and provides skin plumping and firming effects. American Academy of Dermatology Poster Exhibit: San Francisco; March 4-6, 2006.
  • Briden ME, Green BA. The Next Generation Hydroxyacids. In: Draelos Z, Dover J, Alam M, eds. Procedures in Cosmetic Dermatology: Cosmeceuticals. Philadelphia, PA: Elsevier Saunders 2005; 205-212.
  • Edison BL, Green BA, Wildnauer RH, Sigler ML. A polyhydroxy acid skin care regimen provides antiaging effects comparable to an alpha-hydroxyacid regimen. Cutis 2004;73(suppl 2):14-17.
  • Grimes PE, Green BA, Wildnauer RH, Edison BL. The use of polyhydroxy acids (PHAs) in photoaged skin. Cutis 2004;73(suppl 2):3-13.
  • Green BA, Edison BL, Lee Y. Treatment of Photoaged Hands. Cosmetics & Toiletries 2002;117(10):49-54.
  • Green BA., Edison BL, Wildnauer RH, Sigler ML. Lactobionic acid and gluconolactone: PHAs for photoaged skin. Cosmetic Dermatology 2001;9:24-28.
  • Bernstein EF, Green BA, Edison B, Wildnauer RH. Poly hydroxy acids (PHAs): clinical uses for the next generation of hydroxy acids. Skin & Aging 2001;9(Suppl):4-11.

2. Compatible with Clinically Sensitive Skin: The PHA acids and lactones are better tolerated by sensitive skin than traditional AHAs. An open-label evaluation of a PHA (gluconolactone) skincare system was conducted on 30 females with acne rosacea and atopic dermatitis (normally unable to tolerate glycolic acid products). Following 12 weeks of twice daily use, results demonstrated that these PHA products are compatible with these clinically sensitive skin conditions. This gentleness is further supported by the consistently lower scores for PHA creams in the Cumulative Irritation Studies and in sting tests.

  • Bergfeld WF, Remzi BK, Green B, Patel P, Ravas R: An Evaluation of the Gluconolactone Sensitive Skin Care Products. Amer Acad of Derm Poster Exhibit: Orlando, February, 1998.
  • Bernstein EF, Green B, Edison B, Wildnauer R: Poly Hydroxy Acids (PHAs): Clinical Uses for the Next Generation of Hydroxy Acids. Supplement to Skin & Aging. September 2001; 9:4-11.
  • Rizer R, Turcott A, Edison B, Outwater S, Trookman N, Ciociola A, Kohut B: An Evaluation of the Tolerance Profile of a Complete Line of Gluconolactone-Containing Skin Care Fomulations in Atopic Individuals. Supplement to Skin & Aging. September 2001; 9:18-21.
  • Rizer R, Turcott A, Edison B, Outwater S, Trookman N, Ciociola A, Kohut B: An Evaluation of the Tolerance Profile of Gluconolactone-Containing Skin Care Fomulations in Individuals with Rosacea. Supplement to Skin & Aging. September 2001; 9:22-25.
  • Green B, Wildnauer R, Edison B: Lactobionic Acid- a Novel Polyhydroxy Bionic Acid for Skincare. Amer Acad of Derm Poster Exhibit: San Francisco, March 2000.
  • Kohut B, Outwater S, Ciociola A, Wendling S, Nayak A: The Safety Profile of a Complete Line of Newly Formulated Skin Care Products Containing the Poly Hydroxy Acid, Gluconolactone. Supplement to Skin & Aging. September 2001; 9:12-17.
  • Data on file, NeoStrata Company, Inc.

3. Combination with Topical Drugs to Enhance Therapeutic Outcomes: PHAs provide therapeutic benefits to skin that are often complementary and additive to the effects of topical drugs. Increased efficacy, improved tolerability and increased cosmetic benefits (skin smoothing) were found when PHA (gluconolactone) was combined with azelaic acid in the treatment of rosacea. PHA can also be used to provide exfoliation benefits and reduce irritation potential of benzoyl peroxide in the treatment of acne. PHAs are compatible with topical retinoid therapy in the treatment of acne and are recommended to be used in combination with topical retinoids to increase moisturization and reduce redness.

  • Draelos ZD, Green BA, Edison BL. An evaluation of a polyhydroxy acid skin care regimen in combination with azelaic acid 15% gel in rosacea patients. J Cosmet Dermatol 2006;5:23-29.
  • Kakita LS, Green BA. A review of the physical and chemical properties of alpha-hydroxyacids (AHAs) and polyhydroxy acids (PHAs) and their therapeutic use in pharmacologics. American Academy of Dermatology Poster Exhibit: San Francisco; March 4-6, 2006.
  • Grimes PE, Green BA, Wildnauer RH, Edison BL. The use of polyhydroxy acids (PHAs) in photoaged skin. Cutis 2004;73(suppl 2):3-13.

4. Barrier Conditioning: The PHA acids and lactones are significantly more barrier conditioning than the classical AHAs such as glycolic and lactic acids. In a double-blind, randomized, complete-block design clinical study, skin was treated twice daily for four weeks with products containing either glycolic acid, gluconolactone, or lactic acid. The skin was challenged with the known skin irritant sodium lauryl sulfate and significantly less damage occurred in the PHA treated sites as compared to damage in the AHA (glycolic and lactic acid) and vehicle treated sites.

  • Berardesca E, Distante F, Vignoli GP, Oresajo C, Green B: Alpha hydroxyacids modulate stratum corneum barrier function. British J Dermatol 1997; 137:934-938.

5. Water Binding Properties: The PHA acids and lactones are significantly more hygroscopic than the classical AHAs such as glycolic and lactic acids. Humectant studies measuring their respective water attracting and binding properties have shown that lactobionic and gluconolactone have greater water binding and water retention properties than glycolic and lactic acid. Lactobionic acid retains more than 10 times more water that of glycolic or lactic acids and gluconolactone more than 3 times that of glycolic or lactic acid.

  • Green B, Wildnauer R, Edison B: Lactobionic Acid- a Novel Polyhydroxy Bionic Acid for Skincare. Amer Acad of Derm Poster Exhibit: San Francisco, March 2000.
  • Green B: Lactobionic Acid. Skin Inc. November 2000. pp. 62-65.
  • Bernstein EF, Green B, Edison B, Wildnauer R: Poly Hydroxy Acids (PHAs): Clinical Uses for the Next Generation of Hydroxy Acids. Supplement to Skin & Aging. September 2001; 9:4-11.
  • Data on file, NeoStrata Company, Inc.

6. Antioxidant/Chelating Properties: The PHA acids and lactones are more potent antioxidants than glycolic or lactic acids and comparable to citric acid and ascorbic acid in preventing oxidation of other drug substances. They are also potent chelating agents.

  • Van Scott EJ, Yu RJ: Bioavailability of alpha-hydroxy acids in topical formulations. Cosmetic Dermatology 1996; 9(6):54-62.
  • Yu RJ, Van Scott EJ: Alpha-Hydroxy Acids: Science and Therapeutic Use. Cosmetic Dermatology Supplement 1-6, 1994.
  • Charloux C, Paul M, Loisance D, Astier A. Inhibition of hydroxyl radical production by lactobionate, adenine, and tempol. Free Radical Bio & Med 1995;19(5):699-704.
  • Data on file, NeoStrata Company, Inc.

7. Free Radical Scavenging Effect: Bernstein et al demonstrated that gluconolactone provides free radical scavenging effects comparable to other well-known compounds such as ascorbic acid and a-tocopherol using an in vitro model of cutaneous photoaging. This significant benefit was attributed to gluconolactone’s ability to chelate oxidation-promoting metals and possibly via direct free radical scavenging effects of gluconolactone.

  • Bernstein EF, Brown DB, Schwartz MD, Kaidbey K, Ksenzenko SM. The Polyhydroxy Acid Gluconolactone Protects Against Ultraviolet Radiation in an In Vitro Model of Cutaneous Photoaging. Dermatologic Surgery, Inc. 2004; 30:1-8.

8. Sun-Sensitivity: The PHA acids and lactones do not cause sun-sensitivity of the skin as reflected by the production of sunburn cells. In two clinical studies, the skin sites treated for four weeks with either the PHAs gluconolactone or glucoheptonolactone showed no statistically significant increase in the production of sunburn cells following a controlled level of ultraviolet radiation exposure. In contrast, glycolic acid treated sites exhibited a significant increase in sunburn cells following irradiation.

  • Green BA, Edison BL, Wildnauer RH. Polyhydroxy acids (PHAs) provide conditioning effects to skin without increasing sensitivity to uv light. Amer Acad of Derm Poster Exhibit: New Orleans, March, 2002.
  • Bernstein EF, Brown DB, Schwartz MD, Kaidbey K, Ksenzenko SM. The Polyhydroxy Acid Gluconolactone Protects Against Ultraviolet Radiation in an In Vitro Model of Cutaneous Photoaging. Dermatologic Surgery, Inc. 2004; 30:1-8.