A 24-week, randomized, open-label, single-center, non-control trial in London, UK, enrolled HIV-positive patients with facial lipoatrophy. The patients were randomly assigned to one of two study arms. Patients in the “immediate-treatment” arm received New-Fill® injections bilaterally overlying the buccal fat pads on day one and then two and four weeks later. Patients in the “delayed-treatment” arm received injections at weeks 12, 14, and 16.
This study was designed to evaluate the association between treatment and improvement in both subjective and objective outcomes. Lipoatrophy was defined by patient-agreed and physician-agreed changes. Ultrasound measurements and photographic assessments were performed. Patients also filled out the Hospital Anxiety and Depression Scale (HADS) at each visit. tadalis sx
Of the 30 patients who were enrolled in this study, 28 (93%) were men. The mean age of the patients was 41 (range, 32-60 years); 72% of the patients were white. Protease inhibitors were used for an average of 43.7 months (range, 21.5-58.8 months); NRTIs were used for an average of 79.4 months (range, 55-118.3 months).
Patients were excluded from the study if they were receiving anticoagulant therapy or if they had a prior history of facial surgical or cosmetic interventions for their facial lipoatrophy.
All patients underwent three sessions of New-Fill® injections into their cheeks and nasolabial areas. At week 12, there was a statistically significant difference in mean increases in dermal thickness between the two groups. The immediate-treatment arm noted an average increase of 4 to 5 mm, but no change was observed in the delayed-treatment arm (P < .001). At the end of the study, however, there were no differences in dermal thickness between the two groups.
During the study, anxiety and depression declined in both groups. Anxiety scores tended to show a difference between the two treatment arms at week 12, which was the point at which the second arm underwent the initiation of injections. No significant changes in viral load, CD4+ count, or blood parameters occurred during the trial.
ADVERSE DRUG REACTIONS
Data on the ADEs resulting from Sculptra™ injections have been compiled from four clinical trials. Table 3 summarizes the most common ADEs that have been reported.
Table 3 Number of Patients with Treatment-Related Adverse Events after Therapy for Facial Wasting
C & W Study
|APEX 002 Study||Blue Pacific St|
|1 (1%)||30 (30%)|
|3 (3%)||17 (17%)|
|19 (19%)||15 (15%)|
|Injection-site subcutaneous papule||26 (52%)|
|6 (6%)||13 (13%)|
The results from the APEX-002 Study and the Blue Pacific Study (Aesthetic Medical Group) in Hermosa Beach, California, which are still ongoing, are provided for safety information only. These two, single-center, open-label, 12-month studies each enrolled 99 HIV-positive patients between ages 31 and 65 years with facial lipoatrophy. Most of these patients were white men, as in the previous trials.
Although no significant drug interactions have been reported with the use of Sculptra™, caution is warranted for patients who are also receiving anticoagulant agents because they may be at an increased risk of hematoma formation or localized bleeding at the injection site.