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FLASH (lipoatrophy)

Clinical trial • Reported • 9 May 2007
This trial is concluded. This means the trial has been completed. The results of the trial are summarised in the 'results' section of this page. You cannot enrol in this trial.

About this trial

The FLASH study was designed to assess treatment with polylactic acid for facial fat loss - a condition called lipoatrophy associated with taking HIV drugs

Polylactic acid (marketed as Sculptra and also formerly known as New-Fill) is a substance which is injected into areas of the face affected by fat wasting. Participants in the trial were randomly assigned to receive the treatment immediately or after a six-month delay

The study assessed whether this cosmetic surgery procedure is effective in addressing fat loss, how long any effect lasts and whether the product and procedure are safe and well-tolerated.

Official title:

A multi-centre, open-label, randomised study to assess the efficacy, durability, and safety of immediate versus deferred injections of poly-L-Lactic acid for HIV facial lipoatrophy

What is this trial studying?Side effect management
Start date:January 2006

This may be the proposed or expected start date for trials which have not yet started.

How many participants will this trial enrol?100

The exact number of participants may be lower or slightly higher than this. Some trials also have specific quotas for participants from each state, city or clinic.

How long is this trial planned to go for?Participants in this trial will be asked to follow the trial protocol for 48 weeks. Following the conclusion of the trial, participants will be followed up for a further 96 weeks.
Links to further information:
Can I access this treatment other than by enrolling in this trial?

Sculptra is a licensed product. To use this product you would need to meet the cost of the treatment, plus the costs of the plastic surgery to administer it.

Tags:facial wasting, Lipodystrophy and lipoatrophy, plastic surgery, polylactic acid, treatment side effects

Who can enrol in this trial?

You may be eligible to participate in this trial if you meet the following criteria:

  • At least 18 years old
  • Have taken HIV treatments in the past

  • Moderate to severe facial fat loss due to HIV treatments

  • Previously used two or more HIV antiretroviral treatments
  • If you are taking treatments, you need to be on a stable combination with no immediate plans to switch drugs
  • If you are NOT currently taking treatments you should not be planning to commence within the first six months of the study.

You will not be eligible to participate in this trial if you meet any of the following criteria:
  • Have taken HIV treatments in the past

  • Current use of steroids or human growth hormone

  • Current HIV wasting
  • Current use of antiocoagulant/blood thinning drugs
  • Prior use of Sculptra/New-Fill or other similar treatments
  • For other criteria, discuss with doctor.

This is a summary of key inclusion and exclusion criteria for this trial. There may be other criteria which may exclude some people from participation in this trial. Some laboratory tests may also be required. Consult your doctor, or view the trial protocol or informed consent documentation to see the full range of exclusion and inclusion criteria.

Results:

An analysis of the outcomes at 24 weeks found that treatment with Sculptra did not increase overall "volume" of facial tissue, as had been hypothesised. Injections did appear to improve facial volume at the direct sites of injection, although the effect was less measurable than in other studies of this product. However, participants in the study felt their physical appearance had improved following treatment with Sculptra and their referring doctors agreed.

Disclaimer

While NAPWA has taken every care to compile the information on this page and to keep it up-to-date, we cannot guarantee its correctness and completeness.

  • Before making the decision to participate in any clinical research, read our background information.
  • Email NAPWA if you have any questions or comments about this trial
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This Clinical trial was first published on 9 May 2007 — more than five years ago.

While the content of this clinical trial was checked for accuracy at the time of publication, NAPWA recommends checking to determine whether the information is the most up-to-date available, especially when making decisions which may affect your health.

This article may contain medical information. NAPWA makes every reasonable effort to ensure the information on this website is accurate, reliable and up-to-date, including obtaining technical reviews by medically-qualified reviewers, however the authors of information on this website are not qualified to give medical advice, except where explicitly stated.

The content of this website is intended to support, not replace, the relationship between people living with HIV/AIDS and their medical advisers, and is not intended as a substitute for medical advice.

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