Hyaluronic Acid Treatment of Facial Fat Atrophy in HIV-positive Patients

H Bugge; A Negaard; L Skeie; B Bergersen

Disclosures

HIV Medicine. 2007;8(8):475-482. 

In This Article

Methods

The patients were primarily recruited from the Oslo HIV Cohort 2000, a study in which the body composition changes and cardiovascular risk factors of 308 ambulatory HIV-positive patients have been evaluated.[3,10] In May 2004, a letter of invitation was sent to all Oslo HIV Cohort patients who were still alive and had a known address; in total, 278 patients. Information about the lipoatrophy treatment study was also sent to patient organizations and HIV health providers in Oslo, Bergen, Trondheim and Tromsoe. HIV-infected patients older than 18 years of age with severe nasogenian atrophy (readily noticeable to a casual observer) that had not previously been treated with injectable fillers were considered eligible for inclusion. The study protocol was evaluated by the Regional Committee for Medical Research Ethics and approved by the Norwegian Data Inspectorate. This study has been conducted in full accordance with the World Medical Association Declaration of Helsinki.

The treatment was given in one or two sessions only. At baseline, the patients received an injection of approximately 1.5-2.0 mL hyaluronic acid in each cheek in the nasogenian area. A touch-up treatment was offered at week 4, and 15 of 20 patients had an injection of approximately 1.0 mL in each cheek at week 4. No more touch-up treatments were given in the following year.

All the injections were performed by the same plastic surgeon at the out-patient clinic of the Department of Plastic Surgery. The skin area was pen-marked with the patient in an upright position before the patient lay down for treatment. Under local anaesthesia, a sharp 18-gauge cannula was used to perforate the skin laterally, just below the cheek bone. A blunt-tipped cannula with side-exit (1.2 x 70 mm; 18 gauge) was then inserted downwards and subcutaneously on each side, to make a tunnel. The tunnel was then filled with Restylane SubQ gel while the cannula was being retracted. Filling with Restylane SubQ was carried out using a fanning injection technique (12-16 tunnelations) (Fig. 1). At the end of each treatment, the cheeks were gently massaged in order to shape the filler material to achieve optimal contour.

Patients were evaluated using digital photography, ultrasound and clinical examinations, which included the use of scales to measure satisfaction with facial appearance and self-esteem at baseline (preoperatively), and at weeks 6, 24 and 52. Following each treatment and at weeks 24 and 52, patients were asked to complete a questionnaire about the following adverse events: swelling, tenderness, pain, redness, lumps and fever. Patients were assessed using the Global Aesthetic Improvement Scale at weeks 6, 24 and 52.

The injection technique.

Standardized ultrasonography was used to measure the total cutaneous thickness (epidermal, dermal and subcutaneous thickness) in the nasogenian area, which is located below the malar bone in front of the masseter muscle. The examination was conducted by a radiologist, using a scanner (Acuson-Siemens Sequoia 512; Siemens Medical Solutions, Mountainview, CA) equipped with a 14-MHz linear array transducer. A large amount of acoustic coupling gel was used and the scanning was performed with minimal pressure. Four measurements were made from each nasogenian area and a mean value (right+left cheek)/2 was calculated at each visit. All the ultrasonographic examinations were recorded. A treatment responder was defined as a patient with a total cutaneous thickness >10 mm.

The Global Aesthetic Improvement Scale [11] is a five-grade subjective test for efficacy analysis. The physician and patient independently compared the preoperative photograph with the treated face and answered the question: 'How would you describe the degree of improvement?' Possible responses were (1) very much improved, (2) moderately improved, (3) somewhat improved, (4) no change or (5) worse.

Patients were asked to record how satisfied they were with their facial appearance in relation to their lipoatrophy on a 10-cm visual analogue scale from 'not satisfied at all' to 'completely satisfied'. The results were translated to numbers from 0 to 100 by measuring in millimetres from the beginning of the scale.

Patients were also asked to complete a questionnaire to assess self-esteem at each visit. The Rosenberg Self-Esteem Scale[12] is a widely-used self-esteem measure in social science research and was used to capture information about possible changes in patients' self-esteem following treatment with hyaluronic acid. The scale consists of 10 statements dealing with general feelings about oneself. For example, 'On the whole, I am satisfied with myself.' Responses were given on a seven-point scale from 0 (strongly disagree) to 6 (strongly agree) and scores ranged from 0 (low self-esteem) to 6 (high self-esteem).

Related samples tests were used to compare values obtained at the first and second visits: the Wilcoxon signed-rank test was used for continuous variables and the McNemar test for binary variables. The level of significance used was 5%. Results are presented as mean±standard deviation, unless otherwise stated.

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