Sculptra Post Approval FDA required study

[Guest guest]

,

Per our conversation last night, below please find details on the Sculptra Phase IV trial. Hope this helps.

(Although we are not certain, we believe that this trial will eventually be listed on clinicaltrials.gov web-site--this has not happened at this point.)

Good luck.

SCULPTRA PHASE IV

A phase IV study was initiated in late September 2005 and will last 5 years. The goals of the study are to evaluate, by Fitzpatrick skin type and by gender, the long‑term safety of poly-L-lactic acid injection(s) in human immunodeficiency virus subjects with facial lipoatrophy and to secondarily evaluate the incidence of hypertrophic scars or keloids in subjects by Fitzpatrick skin types IV‑VI, assessed approximately 6 months after completion of treatment; to evaluate adverse events (AEs) by Fitzpatrick skin type and gender; and to evaluate the Quality of Life (QOL) and body image benefit associated with the treatment of facial lipoatrophy.

Approximately 20 U.S. study centers will enroll 300 patients which will include females and males of color (Fitzpatrick Classification of Skin Types IV - VI). The FDA will receive an analysis of safety endpoints.

Boyce

Manager, Public Relations

Dermik Laboratories

Regards, VergelProgram for Wellness Restoration ThanksLecture Dates:NY Oct 12 & 13 (Spanish and English),El Paso Oct 10, San Francisco Oct 25, Fort Lauderdale Oct 14, POZ Cruise- Miami- Oct 15-21, Houston Sept 29, Austin Nov 1, San Diego Nov. 3, Oaxaca Nov 28-29, Laredo Dec 7, Atlanta Dec 14,

DisclaimerThis information (and any accompanying printed material) is not intended to replace the attention or advice of a physician or other health care professional. Anyone who wishes to embark on any dietary, drug, exercise, or other lifestyle change intended to prevent or treat a specific disease or condition should first consult with and seek clearance from a qualified health care professional.