JOURNAL OF LAW, ECONOMICS & POLICY WINTER 2010 CONTENTS 5TH ANNUAL JUDICIAL SYMPOSIUM ON CIVIL JUSTICE ISSUES GEORGE MASON JUDICIAL EDUCATION PROGRAM DECEMBER 5-7, 2010 EDITED TRANSCRIPTS J. Russell Jackson, Partner, Skadden, Arps, Slate, Meagher & Flom LLP Robert S. Peck, President, Center for Constitutional LitigationModerator: Paige V. Butler, Director, George
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Epionce.plMelano Corrective System vs. Obagi® Nu Derm for Hyperpigmentation
Due to the high irritation rates, photosensitivity and atrophy of the
(AM only). Clear and Blender contain prescription 4% hydroquinone skin, many of the current therapy options for hyperpigmentation and prescription tretinoin 0.05% is added to the Blender. The regimen require a patient to stop use of the treatment product for a period of for Cell 3 consisted of Epionce Gentle Foaming Cleanser, MelanoLyte time. There is then a relatively high risk of recurrence of the hyperpig- Tx and Renewal Facial Lotion applied twice daily with Ultra Shield mentation during this time period. Patients are often unhappy with Lotion SPF 50 applied only in the morning. The MelanoLyte PRO was the negative side effects in conjunction with the resolution results not used by Cell 3. All regimens for each Cell occurred for the initial 12 of their treatment regimen. The Epionce® Melano Corrective System (MCS), which includes the MelanoLyteTx™ and MelanoLyte™ PRO, was developed to help solve the problems of current regimens. During the 6 week regression period, Cell 1 stopped using both the MelanoLyte Tx and the MelanoLyte PRO, Cell 2 stopped using the Clear The current gold standard for hyperpigmentation is prescription 4% and Blender products and Cell 3 stopped using the MelanoLyte Tx.
hydroquinone (HQ) combined with tretinoin (TR) 0.05%. Ascorbic acid, corticosteroids, exfoliants or herbal extracts are added to the above to improve efficacy and tolerance of the prescription products. Table 1 shows the safety results from this study against baseline. As One of the most popular is the Obagi® Nu Derm System (OND), which seen in Table 1, Cells 1 and 3 had excellent safety data. However, by is a complex multi-stage regimen containing all of the above, except week 4, the Cell 2 panelist regimens had to be modified due to intolerable contact reactions. Not one panelist in Cell 1 or 3 had to make such adjustments. Additionally, Table 1 shows that after 12 MCS contains a unique blend of synergistic active ingredients, each weeks, Cell 2 had increased erythema by 66.6% and scaling/dryness of which individually has been found to improve the appearance of by 200%. Additionally, it induced peeling in 44.4% at week 4, and hyperpigmentation of human skin in in vivo trials. Moreover, each 27.7% at week 12. At week 18, 6 weeks following the completion of has been compared to and shown to have superiority to the most treatment, Cell 2 panelists continued to suffer from symptoms that commonly used actives. Neither product contains hydroquinone, included a 53.3% increase in erythema over baseline, however, tretinoin, ascorbic or glycolic acid, soy, tea, kojic acid or niacinamide. scaling/dryness improved 66.6% over baseline. In conclusion, Cell 1 Each of the actives in the MCS has a different mechanism of action, and 3 were highly statistically superior (p<0.001) in safety to Cell 2. thus all contribute to expected improved efficacy and safety. Table 2 shows the efficacy results from this study against baseline. In a dermatologist-assessed controlled clinical trial, the concept Four types of hyperpigmentation were evaluated including lentigines behind the Melano Corrective System was validated. The study was (freckling), mottled hyperpigmentation, hormonal (melasma) and conducted during the winter in Colorado to maximally stress the skin dyschromia. Cell 1 was statistically significant (p<0.05) to Cell 2 in for risk of reactions to the product and rebound post-inflammatory relieving mottled hyperpigmentation on the whole face and cheeks at 18 weeks. Cell 1 also showed a statistically significant improve-ment in lentigines at 8, 12 and 18 weeks, while the lentigines for Cell 2 panelists rebounded to become worse than baseline by week 18 Two Epionce regimens were compared with Obagi Nu Derm System, (+31.2%). Total facial and forehead dyschromia had comparable reso- consisting of prescription tretinoin 0.05% and hydroquinone 4% in lution of hyperpigmentation at all time points with all three Cells. For an 18-week prospective, parallel, controlled clinical trial during the melasma, Cell 1 had a statistically significant reduction (19.3%) on the fall and winter months. The 56 panelists were randomized into three forehead and Cell 3 had a statistically significant reduction (19.1%) on cells. 19 were treated with the full MCS, 19 were treated with only the the cheeks, over Cell 2 which showed a reduction of 10.5% and 12.7%, MelanoLyte Tx, and 18 were treated with OND. Three racial groups respectively at 4 weeks. Chin melasma showed a trend toward statisti- - Caucasian, Hispanic, Asian - were included with mild to severe hy- cal significance (p<0.10) of Cell 1 over Cell 2 at both the 12 and 18 perpigmentation. Assessments were performed by expert investiga- week time points. As seen in Table 2, Cell 1 was shown to reduce chin tors at 0, 4, 8, 12 and 18 weeks for both safety and efficacy. A 6 week melasma by 57.8% at 12 weeks, compared to 26.8% improvement regression period occurred between weeks 12 and 18. During this time for Cell 2. At 18 weeks, Cell 1 panelists had a 29.6% reduction in chin period, all three cells discontinued use of the treatment products to determine rebound effect and continued irritation reactions. DISCUSSION
The regimen for Cell 1 consisted of Epionce Gentle Foaming Cleanser, Epionce Melano Corrective System appears to be the first non- MelanoLyte Tx and Renewal Facial Lotion applied twice daily with Ultra prescription system to directly compare itself to the Obagi Nu Derm Shield Lotion SPF 50 applied only in the morning. Once a week, the system - the prescription gold standard for treating visible signs of panelists applied the MelanoLyte PRO treatment mask in the evening. hyperpigmentation. The MCS regimen is shown to be comparable in The regimen for Obagi Nu Derm System, Cell 2, consisted of Foaming efficacy, but is overall profoundly safer. The increase in safety should Cleanser, Toner, Clear, Exfoderm, Blender, Physical UV Block SPF 32 allow for regular use of the MCS, providing continued resolution of visible hyperpigmentation over the long-term.
Melano Corrective System vs. Obagi Nu Derm for Hyperpigmentation, cont.
SS (Statistically significant p<0.05); NS (Not statistically significant p>0.10); T (Trend towards statistical significance p<0.10 - p<0.05) HS (Highly statistically significant p<0.001); + (indicates a worsening of the parameter); No + (indicates an improvement of the parameter) 0 (indicates panelists did not exhibit the parameter)
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