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NCT00765583 · ClinicalTrials.gov registry record · Phase 4

A Study to Determine How Long Restylane® Will Last After Initial Treatment With 2 Different Re-treatment Schedules.

A Phase 4 study of Rhytids, sponsored by Medicis Aesthetics.

Completed
Registry status
Phase 4
Development phase
75
Enrollment target
3
Study locations

NCT00765583 is a Phase 4 study of Rhytids that has completed, run by Medicis Aesthetics. The registered enrollment target is 75 participants. The trial reports 3 study locations across 3 states.

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The verdict

NCT00765583, a Phase 4 study of Rhytids, has completed, sponsored by Medicis Aesthetics.

COMPLETED
Registry status
Phase 4
Development phase
75 participants
Enrollment target
3
Study locations

Study Summary

A total of 75 subjects will be enrolled into a 36 month study. Subjects will be treated with Restylane® on both sides of the face (nasolabial folds) at the first visit, on one side of the face at month 4.5 and on the other side of the face at month 9. Both sides of the face will then be treated again at month 18. The subjects will evaluate themselves and will also be evaluated by the treating doctor and a blinded evaluator (a person that does not know when the different sides of the face are treated). Side effects and medications taken during the study will also be recorded.

Conditions Studied

Interventions

  • DRUG Restylane

Study Locations (3)

Florida

  • Dermatology Research Institute, LLC - Coral Gables

Illinois

  • Dayan Facial Plastic Surgery Institute - Chicago

New York

  • Rhoda Narins, MD - White Plains

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2005-11
Est. Completion 2009-02
Phase Phase 4

Sponsor

Medicis Aesthetics

1 total trials

What the Registry Record Tells You About NCT00765583

The ClinicalTrials.gov registry entry for NCT00765583 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medicis Aesthetics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Rhytids appearing as the primary indexed condition, and to 1 intervention - of which Restylane is the first listed.

NCT00765583 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Florida, Illinois, New York.

Frequently Asked Questions

What is clinical trial NCT00765583 about?

NCT00765583 is a clinical study titled "A Study to Determine How Long Restylane® Will Last After Initial Treatment With 2 Different Re-treatment Schedules.". A total of 75 subjects will be enrolled into a 36 month study. Subjects will be treated with Restylane® on both sides of the face (nasolabial folds) at the first visit, on one side of the face at month 4.5 and on the other side of the face at month 9. Both sides of the face will then be treated agai...

What is the current status of trial NCT00765583?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 75 participants. The study started on 2005-11. Estimated completion is 2009-02.

What conditions does trial NCT00765583 study?

This clinical trial studies the following conditions: Rhytids.

What interventions are being tested in trial NCT00765583?

The interventions under investigation include: Restylane (DRUG).

Who is sponsoring clinical trial NCT00765583?

This trial is sponsored by Medicis Aesthetics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00765583 being conducted?

This trial has 3 study locations across Florida, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.