Efficacy of Arnica D1 Ointment After Upper Blepharoplasty

Blepharoplasty Clinical Trial

— ARINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598909
• Other study ID #: ARINE Study
• Status: Completed
• Phase: N/A
• First received: May 12, 2012
• Last updated: August 21, 2015
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: August 2015
• Source: Isala
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients undergoing primary blepharoplasty

Exclusion Criteria:

• use of anticoagulants

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharoplasty
• Upper Eyelid Blepharoplasty

Intervention

Drug:
• Arnica
Application of Arnica ointment periorbitally
• Placebo ointment
Application of Arnica ointment, twice a day, for the period of one week.

Locations

Country	Name	City	State
Netherlands	Isala Klinieken	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Wynand BWH Melenhorst, MD

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical outcome	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	No
Secondary	amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction		3, 7 and 42 days postoperatively	No