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Efficacy of Arnica D1 Ointment After Upper Blepharoplasty (ARINE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01598909
First Posted: May 15, 2012
Last Update Posted: August 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wynand BWH Melenhorst, MD, Isala
  Purpose
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.

Condition Intervention
Blepharoplasty Upper Eyelid Blepharoplasty Drug: Arnica Drug: Placebo ointment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Arnica D1 Ointment After Upper Blepharoplasty: a Randomized, Double-blind Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Wynand BWH Melenhorst, MD, Isala:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction [ Time Frame: 3, 7 and 42 days postoperatively ]

Enrollment: 136
Study Start Date: January 2013
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing primary blepharoplasty

Exclusion Criteria:

  • use of anticoagulants
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598909


Locations
Netherlands
Isala Klinieken
Zwolle, Netherlands, 8000 GK
Sponsors and Collaborators
Wynand BWH Melenhorst, MD
Investigators
Principal Investigator: W Melenhorst, MD PhD Isala Klinieken, Zwolle
  More Information

Responsible Party: Wynand BWH Melenhorst, MD, MD, PhD, Isala
ClinicalTrials.gov Identifier: NCT01598909     History of Changes
Other Study ID Numbers: ARINE Study
First Submitted: May 12, 2012
First Posted: May 15, 2012
Last Update Posted: August 25, 2015
Last Verified: August 2015

Keywords provided by Wynand BWH Melenhorst, MD, Isala:
blepharoplasty
arnica
homeopathy