Safety & Performance of Princess® FILLER for the Treatment of Facial

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

In this study, eligible patients with the medical indications (facial lipoatrophy, morphological asymmetry of the face, or debilitating scars) will be treated with Princess® FILLER, and then will return for follow-up assessments 2, 4 and 24 weeks after the treatment. A touch-up treatment may be done 2 weeks after the treatment.

See also
Status	Clinical Trial	Phase
Completed	`NCT00360932` - Facial Lipoatrophy Correction Experience With SCULPTRA ("FACES" Study)
Completed	`NCT03050749` - Safety and Performance of Princess® VOLUME for the Treatment of Facial Lipoatrophy, Asymmetry or Scars	N/A
Completed	`NCT00333684` - Safety, Efficacy and Psychological Effects of Treating Antiretroviral Drug-Induced Facial Lipoatrophy With Bio-Alcamid	Phase 2

NCT number	NCT03050723
Study type	Interventional
Source	Croma-Pharma GmbH
Contact
Status	Completed
Phase	N/A
Start date	November 20, 2016
Completion date	January 16, 2018

Safety and Performance of Princess® FILLER for the Treatment of Facial Lipoatrophy, Asymmetry or Scars — FLASH 1

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms