NCT00407914

Brief Summary

The purpose of this study is to compare the effectiveness of Aquamid and Restylane in aesthetically enhancing nasolabial folds 6 months after treatment and to evaluate the safety of Aquamid through 12 months after treatment. The study includes an extended follow up to 24 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
315

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 8, 2009

Status Verified

October 1, 2009

Enrollment Period

1.7 years

First QC Date

December 4, 2006

Last Update Submit

October 6, 2009

Conditions

Facial Wrinkles

Keywords

wrinklessoft tissue fillerAquamid

Outcome Measures

Primary Outcomes (2)

  • Wrinkle Assessment Scale

    Baseline, 3, 6, 9, 12 Months

  • Adverse device effects

    continuosly

Secondary Outcomes (3)

  • Global Aesthetic Improvement Scale

    Optimal treatment, 3, 6, 9 and 12 Months

  • Injection site reactions

    After injection

  • Adverse events

    continuosly

Study Arms (2)

1

EXPERIMENTAL

Aquamid

Device: Aquamid

2

ACTIVE COMPARATOR

Restylane

Device: Restylane

Interventions

AquamidDEVICE

Subcutaneous injection

1
RestylaneDEVICE

Injection in dermis

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • interested on soft tissue augmentation for the nasolabial folds
  • moderate to severe nasolabial fold

You may not qualify if:

  • sensitivity to anesthetics
  • allergy to hyaluronic acid
  • previous treatment with permanent fillers in the treated area
  • recent previous aesthetic procedure in the treatment area
  • infected skin areas or autoimmune diseases affecting the skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

White Plains, New York, 10604, United States

Location

Related Publications (1)

  • von Buelow S, von Heimburg D, Pallua N. Efficacy and safety of polyacrylamide hydrogel for facial soft-tissue augmentation. Plast Reconstr Surg. 2005 Sep 15;116(4):1137-46; discussion 1147-8. doi: 10.1097/01.prs.0000179349.14392.a4.

    PMID: 16163108BACKGROUND

Study Officials

  • Silvia Codony

    Contura

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 4, 2006

First Posted

December 5, 2006

Study Start

December 1, 2006

Primary Completion

August 1, 2008

Study Completion

July 1, 2009

Last Updated

October 8, 2009

Record last verified: 2009-10

Locations

US(1)