Highly purified 1000-cSt silicone oil for treatment of human immunodeficiency virus-associated facial lipoatrophy: an open pilot trial

Journal of Drugs in Dermatology, March-April, 2005

Highly Purified 1000-cSt Silicone Oil for Treatment of Human Immunodeficiency Virus-Associated Facial Lipoatrophy: An Open Pilot Trial.

Jones DH, MD, Carruthers A, MD, Orentreich D, MD, et al. Dermatol Surg. 2004;30:1279-1286.

Summary

The authors present an open pilot trial using 1000-cSt silicone oil to evaluate its ability to provide more permanent results for treating HIV-associated facial lipoatrophy. Many current fillers provide temporary treatment options. The authors chose 77 of 415 patients from their practices with facial lipoatrophy who had been treated with either Silikon 1000 or VitreSil 1000, using the micro-droplet serial puncture technique. These patients were chosen because they had complete correction of their lipoatrophy, appropriate pre- and post-treatment photographs, and no prior treatment with permanent fillers. Lipoatrophy was rated using the 5-point Carruthers lipoatrophy severity scale (Stage 0 to Stage 4). The patients' lipoatrophy ranged from mild to severe with no one meeting criteria for very severe lipoatrophy (Stage 4). Patients then underwent microinjections of silicone to areas of facial depression, photography being done at each session. Treatments were separated by at least 1 month or more to allow for localized fibrosis around the silicone droplets. Patients were treated until complete correction. Ninety-one percent of treatment sessions required the use of 2 mL of silicone or less. The mean number of treatments required and the amount of silicone needed significantly increased depending upon the patients' lipoatrophy severity scale rating. More specifically, Stage 1 patients received 3.2 treatments with 5.4 mL of silicone, Stage 2 received 5.6 treatments with 9.3 mL, and Stage 3 received 8.6 treatments with 16.9 mL. In addition, the mean time from first to last injection was also significantly increased depending upon the patients' lipoatrophy severity scale rating. The mean time between the first and last treatment ranged from 100 to 872 days. No adverse events, defined as post-treatment pain, erythema, or edema persisting for longer than 3 days or ecchymosis longer than 2 weeks, were noted after any of the treatments.

Comment

This open-label trial provides a start for a more permanent way to treat HIV-associated facial lipoatrophy. This trial has obvious limitations as it is open-label from the authors' own patient population. However, it does provide data regarding the safety and efficacy of silicone microinjection. Before and after photographs from 7 patients are provided to illustrate the efficacy of this filler. Based on their data, the authors suggest a "rule of threes" regarding treatment of patients with facial lipoatrophy. On average, Stage 1 patients will need 3 treatments with 6 mL of silicone, Stage 2 patients will need 6 treatments with 12 mL of silicone, and Stage 3 patients will need 9 treatments with 18 mL of silicone. Further studies are warranted to evaluate patients with Stage 4 lipoatrophy, to compare different formulations of silicone with each other and with other permanent fillers, and to assess long-term safety and efficacy.