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What is Lipoma Board? A forum and community offering information, alternative treatments, resources and support concerning lipomas, lipomatosis and other related conditions. Surgery shouldn't be the only option! Lipomas are fatty tumors under the skin. Read more >>

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 ATX-101 lipoma injection
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PostPosted: 3/1/11 Tuesday, 3:20 pm 
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Joined:Thu Jan 27, 2011 12:43 pm
A research center in California, Kythera Biopharmaceuticals, has been developing their new product ATX-101 (fat reduction drug) for years now. It is currently in phase three (the phase before the market) but is still suspected to be in trial phase for a some years.

They are actually suggesting that Deoxycholite alone is helping the lipomas to shrink and that Phosphatidylcholine is actually inhibiting the cell death. Source: http://www.kytherabiopharma.com/pdf/200 ... n_vivo.pdf [pdf]

One hundred twenty-nine subjects were randomized in a double-blind, placebo-controlled, dose-ranging study conducted across 10 dermatology and plastic surgery centers in the United States (ATX-101-09-15). Subjects received one of two dosing regimens of ATX-101 (1 mg/cm2 or 2 mg/cm2) or placebo, administered monthly for up to 5 months into the submental area. Clinician assessments were performed at all treatment visits and 4 and 12 weeks after the last treatment visit (week 24 and week 32, respectively). Subject self-assessments and MRI assessments were performed at baseline, treatment visit 5 (week 16) and 12 weeks after the last treatment visit (week 32).

In this study, the 2 mg/cm2 proved to be the more efficacious dose and yielded a statistically significant reduction of unwanted submental fat compared to placebo as measured by physician assessment (p=0.001 and p=0.003, week 24 and week 32, respectively). Evidence of improvement was observed at 1 mg/cm2, indicating that a dose response exists between the two ATX-101 regimens. Physician assessment was performed using a validated, 5-point Clinician-Reported Submental Fat Rating Scale (CR-SMFRS). In addition, the 2 mg/cm2 dose group yielded a statistically significant reduction of submental fat as measured by subject assessment (p<0.05, week 16 and week 32). Subjects assessed submental fat using a 5-point Patient Reported Outcomes (PRO) tool, the Patient-Reported Submental Fat Rating Scale (PR-SMFRS).

“The results from this study are exciting and indicate the potential of ATX-101 as an effective and well-characterized treatment for the aesthetic reduction of small volumes of fat,” said Joel Schlessinger, MD, a board-certified dermatologist and cosmetic surgeon in private practice in Omaha, Nebraska and an investigator in this study. “There are currently no FDA-approved non-surgical treatment modalities for the reduction of fat under the chin. ATX-101 may represent a breakthrough for patients who are seeking a minimally-invasive treatment option for the reduction of unwanted localized submental fat.”
Source: http://www.kytherabiopharma.com/newsroom/

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