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Additional information: The VEGA trial
| Last updated: 25.08.04 |
Investigators from Pitie Salpetriere Hospital in Paris have been following-up 49 highly treatment-experienced men – and one woman - with severe facial lipoatrophy for almost two years.
Between June 2000 and February 2001 New-Fill injections of one vial of New-Fill (0.15g) in each cheek took place at day 0, 15, 30 and 45 with the option of a further fifth injection at day 60, if dermal thickness was still less than 8mm.
No patients discontinued the treatment. No serious adverse events were reported, although some injection site reactions occurred.
Treatment success was assessed using clinical examinations, photographs, and ultrasounds at weeks six, 24, 48, 72, and 96. Quality of life was assessed using a questionnaire at weeks twelve, 24, 48, 72 and 96.
At week six, after the fourth set of injections was administered, 19% of patients had total total cheek skin thickness of 10mm. or more (the study’s primary endpoint); this increased to 41% by week 24 (the study’s primary endpoint); 61% by week 48; before falling to 52% at week 72 and 43% at week 96. The increase in total cheek skin thickness was highly significant (p<0.001).
Quality of life improved also progressively between baseline and week 48.
The investigators concluded that their results are “clinically relevant”, as “aesthetic improvement was clearly observed, accompanied by a significant increase in patient quality of life”.
References
Aubron-Olivier C et al. 8th Conference on Clinical Aspects and Treatment of HIV Infection, Athens. Abs O20, 2001.
Valantin M-A et al. AIDS 17: 2471 – 2477, 2003.