Immediate versus delayed surgical intervention for reconstructive therapy of HIV-associated facial lipoatrophy: a randomized open-label study.
We assessed the safety and efficacy of reconstructive therapy with facial fillers for the treatment of HIV-associated facial lipoatrophy (FLA) through a randomized, controlled, open-label single-center study. A total of 134 HIV-infected patients with severe FLA were randomly assigned to receive immediate (67 patients) or delayed (67 patients) facial injections of poly-l-lactic acid (PLA) or polyacrylamide gel (PAIG). Outcome measures included changes in physician and patient FLA severity scale, adverse events, and changes in health-related quality of life (HRQoL) and anxiety using validated measures. The mean average study follow-up was 27 weeks for the immediate and 25 weeks for the delayed subjects. Adverse events were mild and resolved after a mean of 4 days. Compared to patients randomized to the delayed treatment group, patients assigned to the immediate treatment group had significantly lower physician-rated (0.0 versus -3.0; p < 0.0001) and patient-rated (0.1 versus -1.8; p < 0.0001) FLA severity scores. By contrast, measures exploring HRQoL and anxiety did not show any significant difference between patients randomized to the immediate and deferred groups. Reconstructive therapy with facial fillers was effective and safe and led to significant improvements in FLA severity. However, no significant gains in HRQoL, relational and psychological consequences of body changes, and anxiety-related concerns were observed. Studies should be performed to identify patients who could maximally benefit from filling interventions for FLA.
National Institute for Infectious Diseases Lazzaro Spallanzani, Rome, Italy.
Pasquale
P
Narciso
Raffaella
R
Bucciardini
Valerio
V
Tozzi
Rita
R
Bellagamba
Jelena
J
Ivanovic
Marinella
M
Giulianelli
Sabrina
S
Scevola
Antonio
A
Palummieri
Vincenzo
V
Fragola
Maurizio
M
Massella
Luca
L
Fracasso
Roy
R
De Vita
Paola
P
Pierro
Annamaria
A
Del Maestro
Marco
M
Mirra
Liliana
L
Weimer
D000180:Acrylic Resins / Q000008:administration & dosage / Q000009:adverse effects; D000328:Adult; D000368:Aged; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005782:Gels / Q000008:administration & dosage / Q000009:adverse effects; D015658:HIV Infections / Q000150:complications* / Q000601:surgery*; D039682:HIV-Associated Lipodystrophy Syndrome / Q000601:surgery*; D006801:Humans; D019344:Lactic Acid / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D011091:Polyesters; D011108:Polymers / Q000008:administration & dosage / Q000009:adverse effects; D011788:Quality of Life; D019651:Plastic Surgery Procedures / Q000009:adverse effects* / Q000379:methods*; D000099166:Polyacrylamides
D000180:Acrylic Resins; D005782:Gels; D019344:Lactic Acid; D011091:Polyesters; D011108:Polymers; D000099166:Polyacrylamides; C033616:poly(lactide)