Efficacy of Arnica D1 Ointment After Upper Blepharoplasty (ARINE)

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. Identifier: NCT01598909
Recruitment Status : Completed
First Posted : May 15, 2012
Last Update Posted : August 25, 2015
Information provided by (Responsible Party):
Wynand BWH Melenhorst, MD, Isala

Brief Summary:
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 or disease Intervention/treatment Phase
Blepharoplasty Upper Eyelid Blepharoplasty Drug: Arnica Drug: Placebo ointment Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
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
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction [ Time Frame: 3, 7 and 42 days postoperatively ]

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

Inclusion Criteria:

  • patients undergoing primary blepharoplasty

Exclusion Criteria:

  • use of anticoagulants

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 identifier (NCT number): NCT01598909

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

Responsible Party: Wynand BWH Melenhorst, MD, MD, PhD, Isala Identifier: NCT01598909     History of Changes
Other Study ID Numbers: ARINE Study
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015

Keywords provided by Wynand BWH Melenhorst, MD, Isala: