Efficacy of Arnica D1 Ointment After Upper Blepharoplasty | NCT01598909

Studies
Efficacy of Arnica D1 Ointment After Upper Blepharoplasty

NCT01598909

Sponsor

Wynand BWH Melenhorst, MD

Status

Completed

Last Update Posted

Aug 25, 2015Estimated

Enrollment

136Actual

Phase

Not Applicable

Conditions

Blepharoplasty
Upper Eyelid Blepharoplasty

Interventions

Arnica
Placebo ointment

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

May 12, 2012

First Submission Date that Met QC Criteria

May 12, 2012

First Posted Date

May 15, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2015

Last Update Posted Date

Aug 25, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Arnica ointment	Active Comparator	Drug: Arnica
Placebo ointment	Placebo Comparator	Drug: Placebo ointment
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arnica	Drug	Application of Arnica ointment periorbitally	Arnica ointment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction		3, 7 and 42 days postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing primary blepharoplasty

Exclusion Criteria:

use of anticoagulants

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
W Melenhorst, MD PhD	Isala	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Isala Klinieken		Zwolle		8000 GK	Netherlands

Intervention Browse Module

MeSH Terms

ID	Term
C000712347	Arnicae flos extract

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided