NCT00429520

Brief Summary

Volunteers receive one injection IMD1 basic of correction of nasolabial folds and are followed-up for up to 36 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2005

Shorter than P25 for phase_4

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, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
Last Updated

February 7, 2008

Status Verified

February 1, 2008

First QC Date

January 30, 2007

Last Update Submit

February 5, 2008

Conditions

Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

  • Severity rating scale assessed by independent rater

Interventions

Hyaluronic acid filler/IMD1 basicDRUG

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Merz Pharmaceuticals

Frankfurt, 60318, Germany

Location

Study Officials

  • Johannes Reinmüller, MD

    Klinik am Sonnenberg, Wiesbaden, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 30, 2007

First Posted

January 31, 2007

Study Start

December 1, 2005

Study Completion

December 1, 2006

Last Updated

February 7, 2008

Record last verified: 2008-02

Locations

DE(1)