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NCT01359917 Clinical Trial

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

HIV-Associated Lipodystrophy Syndrome Clinical Trial

Official title:
Psychological Morbidity and Facial Volume in HIV Lipodystrophy:

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01359917
Other study ID # REC06/MRE00/39
Secondary ID
Status Completed
Phase N/A
First received May 23, 2011
Last updated June 9, 2011
Start date August 2006
Est. completion date July 2009

Study information
Verified date March 2006
Source NHS Lothian
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health Service
Study type Observational

Clinical Trial Summary

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.

Description:

as above

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- HIV facial lipoatrophy

- concurrent antiretrovirals

Exclusion Criteria:

- known psychological disorder

- skin allergies

- significant medical problems precluding anaesthesia

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
NHS Lothian

Outcome
Type Measure Description Time frame Safety issue
Primary measurement of 3-D facial volume 3-D facial camera 2 years No
Secondary psychological outcome derriford appearance scale hospital anxiety and depression scale 2 years No
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