Use of Artefill® for Moderate to Severe Atrophic Acne Scar Correction

Atrophic Acne Scar Clinical Trial

Official title: A Phase 3 Randomized Placebo-Controlled Double-Blind Study of the Use of Artefill® for Moderate to Severe Atrophic Acne Scar Correction

Status Completed

Clinical Trial Summary

The purpose of this study is to determine whether Artefill is safe and effective for the correction of atrophic facial acne scars.

Clinical Trial Description

This is a multi-center, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of Artefill for correction of moderate to severe atrophic acne scars.

The study is divided into two study periods. In Period I, scars meeting the treatment criteria will be individually identified, numbered and mapped using photographs and transparent sheets prior to treatment. This mapping will be used to track individual scars throughout the trial. Four (4) weeks following a baseline qualification visit, subjects randomized to treatment will receive one treatment of Artefill or Control (saline), administered by the Treating Investigator. At 72 hours following injections, subjects will be followed-up by telephone to confirm the occurrence of any AEs. Subjects will return to the clinic at 2 weeks for follow-up evaluation, and then at 4 weeks where subjects may receive one optional touch-up treatment. Subjects receiving touch-up treatment will be followed-up by telephone at 72 hours to confirm the occurrence of any AEs, and return for clinic visits at 6 weeks and 8 weeks. All subjects will then return for clinic follow-up at months 3 and 6 (after last treatment).

Period II is open label and will begin at month 6. Artefill group subjects will return to the clinic for assessments at months 9 and 12 (Track A) and Control group subjects will enter Track B, re-establish baseline, and complete additional month 6 visit activities including Artefill treatment. Subjects will receive touch up (if required) 4 weeks later, and be followed for an additional 12 months.

Subjects will be required to abstain from other aesthetic treatment to their face during the study period and failure to do so will be considered a protocol violation. However, if a subject does receive additional aesthetic or non-aesthetic treatments, available information on such treatment will be collected and the subject will be continued to be followed per protocol. Such subjects will not be excluded from the analysis, but will also be evaluated separately. ;

Related Conditions & MeSH terms

• Atrophic Acne Scar
• Atrophy

• NCT number: NCT01559922
• Study type: Interventional
• Source: Suneva Medical, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: February 2012
• Completion date: February 2014