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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 23, 2011

Last Updated Date

June 9, 2011

Start Date ^ICMJE

August 2006

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

measurement of 3-D facial volume [ Time Frame: 2 years ] [ Designated as safety issue: No ]

3-D facial camera

Original Primary Outcome Measures ^ICMJE

measrement of 3-D facial volume [ Time Frame: 2 years ] [ Designated as safety issue: No ]

3-D facial camera

Change History

Complete list of historical versions of study NCT01359917 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

psychological outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]

derriford appearance scale hospital anxiety and depression scale

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Psychological Morbidity and Facial Volume in HIV Lipodystrophy:

Brief Summary

The hypotheses of this study were that:

HIV lipodystrophy is associated with psychological morbidity relating to body image, anxiety and depression.
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.
The DI3D system is a valid and reproducible method of recording and measuring facial 3-D volume.

Detailed Description

as above

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

50 patients with HIV facial lipoatrophy

Condition ^ICMJE

HIV-Associated Lipodystrophy Syndrome

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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

Publications *

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. Epub 2011 Dec 5.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

HIV facial lipoatrophy
concurrent antiretrovirals

Exclusion Criteria:

known psychological disorder
skin allergies
significant medical problems precluding anaesthesia

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01359917

Other Study ID Numbers ^ICMJE

REC06/MRE00/39

Has Data Monitoring Committee

Yes

Responsible Party

Dr Lisa Nelson, NHS Lothian

Study Sponsor ^ICMJE

NHS Lothian

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Kenneth J Stewart, FRCSPlast

NHS Lothian

Information Provided By

NHS Lothian

Verification Date

March 2006

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

To Top