Efficacy of Arnica D1 Ointment After Upper Blepharoplasty (ARINE)

August 21, 2015 updated by: Wynand BWH Melenhorst, MD

Efficacy of Arnica D1 Ointment After Upper Blepharoplasty: a Randomized, Double-blind Placebo-controlled Study

Arnica ointment is currently used in homeopathic preparations for strains and bruises. In the field of plastic surgery, some surgeons advise patients undergoing blepharoplasty to use Arnica in order to prevent postoperative ecchymosis, swelling and pain. Thus far, no decent study evaluated the efficacy of topical Arnica ointment in reducing ecchymosis or surgical outcome after upper blepharoplasty. We hypothesize that application of Arnica ointment postoperatively will reduce the development of ecchymosis and improve outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Zwolle, Netherlands, 8000 GK
        • Isala Klinieken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients undergoing primary blepharoplasty

Exclusion Criteria:

  • use of anticoagulants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Arnica ointment
Drug: Arnica
Application of Arnica ointment periorbitally
Placebo Comparator: Placebo ointment
Drug: Placebo ointment
Application of Arnica ointment, twice a day, for the period of one week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical outcome
Time Frame: 7 days and 6 weeks postoperatively
Overall judgment of surgical outcome, based on the combined analysis of the amount of ecchymosis, swelling and redness, by an unrelated, uninvolved and "blinded" plastic surgeon.
7 days and 6 weeks postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction
Time Frame: 3, 7 and 42 days postoperatively
3, 7 and 42 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wynand BWH Melenhorst, MD

Investigators

  • Principal Investigator: W Melenhorst, MD PhD, Isala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 12, 2012

First Submitted That Met QC Criteria

May 12, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 21, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ARINE Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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