ARINE: Efficacy of Arnica D1 Ointment After Upper Blepharoplasty

• Sponsor: Wynand BWH Melenhorst, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT01598909
• Collaborator: (none)
• Enrollment: 136
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 11.3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jan 1, 2013
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Surgical outcome [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 [3, 7 and 42 days postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients undergoing primary blepharoplasty

Exclusion Criteria:

• use of anticoagulants

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Isala Klinieken	Zwolle		Netherlands	8000 GK

Sponsors and Collaborators

• Wynand BWH Melenhorst, MD

Investigators

• Principal Investigator: W Melenhorst, MD PhD, Isala

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wynand BWH Melenhorst, MD, MD, PhD, Isala
• ClinicalTrials.gov Identifier: NCT01598909
• Other Study ID Numbers: ARINE Study
• First Posted: May 15, 2012
• Last Update Posted: Aug 25, 2015
• Last Verified: Aug 1, 2015

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

Study Results

No Results Posted as of Aug 25, 2015