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Macrolane Prospective Survey

Sponsor
Galderma R&D (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01223066
Collaborator
Pharma Consulting Group AB (Industry)
0
Enrollment
1
Location
30
Actual Duration (Days)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study objective is to evaluate the long term safety when Macrolane Volume Restoration Factor is used in female breasts in clinical practice.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Multi-center, Non-interventional, Prospective Study to Monitor Long Term Safety in Female Subjects After Treatment With Macrolane Volume Restoration Factor 20 and/or Macrolane Volume Restoration Factor 30 in the Breasts.
    Actual Study Start Date :
    Sep 1, 2010
    Actual Primary Completion Date :
    Oct 1, 2010
    Actual Study Completion Date :
    Oct 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Women treated with Macrolane in the breasts

    Outcome Measures

    Primary Outcome Measures

    1. Adverse events [up to 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Females recently treated with Macrolane Volume Restoration Factor in the breasts.

    • Signed informed consent

    Exclusion Criteria:
    • There are no exclusion criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Akademikliniken Stockholm Sweden 115 42

    Sponsors and Collaborators

    • Galderma R&D
    • Pharma Consulting Group AB

    Investigators

    • Principal Investigator: Per Hedén, Md PhD, Akademikliniken Stockholm

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Galderma R&D
    ClinicalTrials.gov Identifier:
    NCT01223066
    Other Study ID Numbers:
    • 31GB0906
    First Posted:
    Oct 18, 2010
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Nov 1, 2012
    Keywords provided by Galderma R&D
    Macrolane

    Study Results

    No Results Posted as of Aug 25, 2022