Efficacy of Arnica D1 Ointment After Upper Blepharoplasty

NCT ID: NCT01598909

Last Updated: 2015-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Blepharoplasty Upper Eyelid Blepharoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arnica ointment

Group Type ACTIVE_COMPARATOR

Arnica

Intervention Type DRUG

Application of Arnica ointment periorbitally

Placebo ointment

Group Type PLACEBO_COMPARATOR

Placebo ointment

Intervention Type DRUG

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

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Arnica

Application of Arnica ointment periorbitally

Intervention Type DRUG

Placebo ointment

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients undergoing primary blepharoplasty

Exclusion Criteria

* use of anticoagulants
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wynand BWH Melenhorst, MD

OTHER

Sponsor Role lead

Responsible Party

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Wynand BWH Melenhorst, MD

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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W Melenhorst, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Isala

Locations

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Isala Klinieken

Zwolle, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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ARINE Study

Identifier Type: -

Identifier Source: org_study_id

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