EcchymosisNCT00363038
Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising
A study testing Petrolatum United States Pharmacopeia (USP), Vitamin K and retinol ointment and Arnica ointment in people with Ecchymosis, run by Northwestern University at 1 site in United States.
Trial summary
The objective of this study is to assess the comparative utility of topical formulations in hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using a 595-nm pulsed-dye laser. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ecchymosis
- What is being tested?
- Petrolatum United States Pharmacopeia (USP), Vitamin K and retinol ointment and Arnica ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Aug 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-60
- Subjects are in good health.
- Subjects have willingness and the ability to understand and provide informed consent for participation in the study.
Who cannot join
- Subjects who are currently using any anticoagulation therapy (Warfarin, Heparin, Aspirin)
- Subjects who have a history of bleeding disorders.
- Subjects who are unable to understand the protocol or to give informed consent
- Subjects with mental illness
- Subjects who are pregnant or nursing.
- Subjects who have active systemic or local infection
- Subjects with systemic or local skin disease.
- Subjects with systemic illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, 60611
About this study
The objective of this study is to assess the comparative utility of topical formulations in hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using a 595-nm pulsed-dye laser. Randomization was used to assign one topical agent (5% vitamin K, 1% vitamin K and 0.3% retinol, 20% arnica or white petrolatum) to exactly one bruise per subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist rated bruises in standardized photographs immediately after bruise creation and at week 2.
- Conditions
- Ecchymosis
- Being tested
- Petrolatum United States Pharmacopeia (USP), Vitamin K and retinol ointment, Arnica ointment, Vitamin K ointment
- Keywords
- Bruising, Topical 20% arnica
- Medical subject headings
- Ecchymosis, Contusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Petrolatum United States Pharmacopeia (USP)Drug
Topical formation applied to bruise twice daily for 2 weeks.
Vitamin K and retinol ointmentDrug
Topical formation applied to bruise twice daily for 2 weeks.
Arnica ointmentDrug
Topical formation applied to bruise twice daily for 2 weeks.
Vitamin K ointmentDrug
Topical formation applied to bruise twice daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bruising | Experimental | Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks. Receives: Drug: Petrolatum United States Pharmacopeia (USP); Drug: Vitamin K and retinol ointment; Drug: Arnica ointment; Drug: Vitamin K ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Bruise Change
Mean change in bruising level detected by dermatologist rater on Visual Analogue Scale at 2 weeks compared with baseline for each of the four agents (Petrolatum USP, Vitamin K and retinol ointment, Vitamin K ointment, Arnica ointment). When responding to a VAS item, respondents specify the bruise severity by indicating a position along a continuous line between two end-points (0 and 10, 10 being the most bruised).
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EcchymosisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363038
- Sponsor's protocol ID
- 1253-015
- Status last verified
- Dec 2021
- First submitted
- 10 Aug 2006
- Last updated
- 3 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Leu S, Havey J, White LE, Martin N, Yoo SS, Rademaker AW, Alam M. Accelerated resolution of laser-induced bruising with topical 20% arnica: a rater-blinded randomized controlled trial. Br J Dermatol. 2010 Sep;163(3):557-63. doi: 10.1111/j.1365-2133.2010.09813.x.
PubMed 20412090
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising
- ClinicalTrials.gov ID
- NCT00363038
- Acronym / sponsor ID
- 1253-015
- Conditions
- Ecchymosis
- Keywords
- Bruising, Topical 20% arnica
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 15 Aug 2006 (estimated)
- Results
- Posted 4 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the comparative utility of topical formulations in hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using a 595-nm pulsed-dye laser. Randomization was used to assign one topical agent (5% vitamin K, 1% vitamin K and 0.3% retinol, 20% arnica or white petrolatum) to exactly one bruise per subject, which was then treated under occlusion twice a day for 2 weeks. A dermatologist rated bruises in standardized photographs immediately after bruise creation and at week 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bruising | Experimental | Drug: Petrolatum United States Pharmacopeia (USP), Drug: Vitamin K and retinol ointment, Drug: Arnica ointment, Drug: Vitamin K ointmentBruises at three time points: immediate after bruise creating, and at 1 and 2 weeks. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 20-60
- Subjects are in good health.
- Subjects have willingness and the ability to understand and provide informed consent for participation in the study.
Key exclusion criteria (8 listed)
- Subjects who are currently using any anticoagulation therapy (Warfarin, Heparin, Aspirin)
- Subjects who have a history of bleeding disorders.
- Subjects who are unable to understand the protocol or to give informed consent
- Subjects with mental illness
- Subjects who are pregnant or nursing.
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 |
|---|---|---|
| Petrolatum United States Pharmacopeia (USP)Topical formation applied to bruise twice daily for 2 weeks. | Drug | Bruising |
| Vitamin K and retinol ointmentTopical formation applied to bruise twice daily for 2 weeks. | Drug | Bruising |
| Arnica ointmentTopical formation applied to bruise twice daily for 2 weeks. | Drug | Bruising |
| Vitamin K ointmentTopical formation applied to bruise twice daily for 2 weeks. | Drug | Bruising |
Primary outcome
Average Bruise Change
Time frame: Baseline and 2 weeks
Mean change in bruising level detected by dermatologist rater on Visual Analogue Scale at 2 weeks compared with baseline for each of the four agents (Petrolatum USP, Vitamin K and retinol ointment, Vitamin K ointment, Arnica ointment). When responding to a VAS item, respondents specify the bruise severity by indicating a position along a continuous line between two end-points (0 and 10, 10 being the most bruised).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20412090Leu S, Havey J, White LE, Martin N, Yoo SS, Rademaker AW, Alam M. Accelerated resolution of laser-induced bruising with topical 20% arnica: a rater-blinded randomized controlled trial. Br J Dermatol. 2010 Sep;163(3):557-63. doi: 10.1111/j.1365-2133.2010.09813.x.
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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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Petrolatum United States Pharmacopeia (USP), Vitamin K and retinol ointment and Arnica ointment in people with Ecchymosis, run by Northwestern University at 1 site in United States.
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 3 inclusion and 8 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 3 Dec 2021. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 4 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Bruise Change (time frame: Baseline and 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00363038, which also lists 1 linked publication.
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 3 Dec 2021.