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CompletedNCT01598909ARINEUpdated Aug 25, 2015

Efficacy of Arnica D1 Ointment After Upper Blepharoplasty

An interventional study of Arnica and Placebo ointment in Blepharoplasty and Upper Eyelid Blepharoplasty, sponsored by Wynand BWH Melenhorst, MD. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-25.

Sponsored by Wynand BWH Melenhorst, MD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Blepharoplasty
  • Upper Eyelid Blepharoplasty

Keywords

  • blepharoplasty
  • arnica
  • homeopathy
03

In context

Lead sponsor

This is the only study on the registry with Wynand BWH Melenhorst, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients undergoing primary blepharoplasty

Exclusion criteria

Exclusion Criteria:

  • use of anticoagulants
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
136 participants (actual)

Study arms

  • Active comparator
    Arnica ointment

    Drug: Arnica

  • Placebo comparator
    Placebo ointment

    Drug: Placebo ointment

  • No intervention
    Control

Interventions

  • DrugArnica

    Application of Arnica ointment periorbitally

  • DrugPlacebo ointment

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

06

What researchers measure

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.

    Time frame: 7 days and 6 weeks postoperatively

Secondary outcomes

  1. amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction

    Time frame: 3, 7 and 42 days postoperatively

07

Study locations

1 site
  • Isala Klinieken
    Zwolle, 8000 GK, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01598909
Lead sponsor
Wynand BWH Melenhorst, MD
Responsible party
Wynand BWH Melenhorst, MD (MD, PhD, Isala) — Sponsor-investigator
First posted
May 15, 2012
Start date
Jan 2013
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Aug 25, 2015

Study contacts

W Melenhorst, MD PhD
principal investigator · Isala

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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