NCT01598909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

1 year

First QC Date

May 12, 2012

Last Update Submit

August 21, 2015

Conditions

BlepharoplastyUpper Eyelid Blepharoplasty

Keywords

blepharoplastyarnicahomeopathy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction

    3, 7 and 42 days postoperatively

Study Arms (3)

Arnica ointment

ACTIVE COMPARATOR
Drug: Arnica

Placebo ointment

PLACEBO COMPARATOR
Drug: Placebo ointment

Control

NO INTERVENTION

Interventions

ArnicaDRUG

Application of Arnica ointment periorbitally

Arnica ointment
Placebo ointmentDRUG

Application of Arnica ointment, twice a day, for the period of one week.

Placebo ointment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients undergoing primary blepharoplasty

You may not qualify if:

  • use of anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isala Klinieken

Zwolle, 8000 GK, Netherlands

Location

MeSH Terms

Interventions

Arnicae flos extract

Study Officials

  • W Melenhorst, MD PhD

    Isala

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 12, 2012

First Posted

May 15, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations

NL(1)