BlepharoplastyARINENCT01598909
Efficacy of Arnica D1 Ointment After Upper Blepharoplasty
A study testing Arnica in people with Blepharoplasty and Upper Eyelid Blepharoplasty, run by Wynand BWH Melenhorst, MD at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blepharoplasty, Upper Eyelid Blepharoplasty
- What is being tested?
- Arnica
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing primary blepharoplasty
Who cannot join
- use of anticoagulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Arnica D1 Ointment After Upper Blepharoplasty: a Randomized, Double-blind Placebo-controlled Study
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.
- Conditions
- Blepharoplasty, Upper Eyelid Blepharoplasty
- Being tested
- Arnica, Placebo ointment
- Keywords
- blepharoplasty, arnica, homeopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArnicaDrug
Application of Arnica ointment periorbitally
Placebo ointmentDrug
Application of Arnica ointment, twice a day, for the period of one week.
| Study group | Role | What they receive |
|---|---|---|
| Arnica ointment | Active comparator | Not described Receives: Drug: Arnica |
| Placebo ointment | Placebo comparator | Not described Receives: Drug: Placebo ointment |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days and 6 weeks postoperatively
Secondary outcomes (1)
amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction
Measured: 3, 7 and 42 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2012 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlepharoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wynand BWH Melenhorst, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wynand BWH Melenhorst, MD, Isala
- Investigators
- W Melenhorst, MD PhD, Principal investigator, Isala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01598909
- Sponsor's protocol ID
- ARINE Study
- Acronym
- ARINE
- Status last verified
- Aug 2015
- First submitted
- 12 May 2012
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Arnica D1 Ointment After Upper Blepharoplasty: a Randomized, Double-blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01598909
- Acronym / sponsor ID
- ARINE / ARINE Study
- Conditions
- Blepharoplasty, Upper Eyelid Blepharoplasty
- Keywords
- blepharoplasty, arnica, homeopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Wynand BWH Melenhorst, MDUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 15 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arnica ointment | Active comparator | Drug: Arnica |
| Placebo ointment | Placebo comparator | Drug: Placebo ointment |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing primary blepharoplasty
Key exclusion criteria (1 listed)
- use of anticoagulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArnicaApplication of Arnica ointment periorbitally | Drug | Arnica ointment |
| Placebo ointmentApplication of Arnica ointment, twice a day, for the period of one week. | Drug | Placebo ointment |
Primary outcome
Surgical outcome
Time frame: 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.
1 secondary outcome
amount of tissue swelling; redness; pain; postoperative recovery; patient satisfaction
Time frame: 3, 7 and 42 days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
W Melenhorst, MD PhD principal investigator
Isala
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arnica in people with Blepharoplasty and Upper Eyelid Blepharoplasty, run by Wynand BWH Melenhorst, MD at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical outcome (time frame: 7 days and 6 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.