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Psychological Morbidity and Facial Volume in HIV Lipodystrophy: Quantification of Treatment Outcome

This study has been completed.
Sponsor:
Information provided by:
NHS Lothian
ClinicalTrials.gov Identifier:
NCT01359917
First received: May 23, 2011
Last updated: June 9, 2011
Last verified: March 2006

May 23, 2011
June 9, 2011
August 2006
July 2009   (final data collection date for primary outcome measure)
measurement of 3-D facial volume [ Time Frame: 2 years ] [ Designated as safety issue: No ]
3-D facial camera
measrement of 3-D facial volume [ Time Frame: 2 years ] [ Designated as safety issue: No ]
3-D facial camera
Complete list of historical versions of study NCT01359917 on ClinicalTrials.gov Archive Site
psychological outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]
derriford appearance scale hospital anxiety and depression scale
Same as current
Not Provided
Not Provided
 
Psychological Morbidity and Facial Volume in HIV Lipodystrophy: Quantification of Treatment Outcome
Psychological Morbidity and Facial Volume in HIV Lipodystrophy:

The hypotheses of this study were that:

  1. HIV lipodystrophy is associated with psychological morbidity relating to body image, anxiety and depression.
  2. Treatment of HIV lipodystrophy using autologous fat transfer, polylactic acid or Bio-alcamid, is associated with an improvement in psychological morbidity and anatomical volume of treated areas.
  3. The DI3D system is a valid and reproducible method of recording and measuring facial 3-D volume.

as above

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

50 patients with HIV facial lipoatrophy

HIV-Associated Lipodystrophy Syndrome
Not Provided
  • autologous fat transfer
    patients received fat transfer for HIV lipodystrophy
  • polylactic acid
    treatment with polylactic acid (PLA) for HIV lipodystrophy
  • bio-alcamid
    bio-alcamid injections
Nelson L, Stewart KJ. Psychological morbidity and facial volume in HIV lipodystrophy: quantification of treatment outcome. J Plast Reconstr Aesthet Surg. 2012 Apr;65(4):439-47. doi: 10.1016/j.bjps.2011.11.024. Epub 2011 Dec 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV facial lipoatrophy
  • concurrent antiretrovirals

Exclusion Criteria:

  • known psychological disorder
  • skin allergies
  • significant medical problems precluding anaesthesia
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01359917
REC06/MRE00/39
Yes
Dr Lisa Nelson, NHS Lothian
NHS Lothian
Not Provided
Principal Investigator: Kenneth J Stewart, FRCSPlast NHS Lothian
NHS Lothian
March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP