Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising
This study has been completed.
Sponsor:
Northwestern University
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT00363038
First received: August 10, 2006
Last updated: November 5, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Ecchymosis |
Drug: Petrolatum United States Pharmacopeia (USP) Drug: Vitamin K and retinol ointment Drug: Arnica ointment Drug: Vitamin K ointment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Topical Vitamin K, Vitamin K and Retinol, and Arnica on Post-Laser Bruising |
Resource links provided by NLM:
Drug Information available for:
Menadione
Retinol
Vitamin A palmitate
Petrolatum
Arnica extract
Vitamin A
U.S. FDA Resources
Further study details as provided by Northwestern University:
Primary Outcome Measures:
- Average Bruise Change [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]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).
| Enrollment: | 16 |
| Study Start Date: | July 2006 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | August 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bruising
Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
|
Drug: Petrolatum United States Pharmacopeia (USP)
Topical formation applied to bruise twice daily for 2 weeks.
Drug: Vitamin K and retinol ointment
Topical formation applied to bruise twice daily for 2 weeks.
Drug: Arnica ointment
Topical formation applied to bruise twice daily for 2 weeks.
Drug: Vitamin K ointment
Topical formation applied to bruise twice daily for 2 weeks.
|
Eligibility| Ages Eligible for Study: | 20 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00363038
Locations
| United States, Illinois | |
| Northwestern University Feinberg School of Medicine, Department of Dermatology | |
| Chicago, Illinois, United States, 60611 | |
Sponsors and Collaborators
Northwestern University
Investigators
| Principal Investigator: | Murad Alam, MD | Northwestern University |
More Information
Publications:
| Responsible Party: | Murad Alam, Associate Professor of Dermatology, Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00363038 History of Changes |
| Other Study ID Numbers: | 1253-015 |
| Study First Received: | August 10, 2006 |
| Results First Received: | November 29, 2010 |
| Last Updated: | November 5, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Northwestern University:
|
Bruising Topical 20% arnica |
Additional relevant MeSH terms:
|
Contusions Ecchymosis Wounds and Injuries Wounds, Nonpenetrating Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Signs and Symptoms Petrolatum Vitamin A Vitamin K Vitamins Retinol palmitate |
Emollients Dermatologic Agents Therapeutic Uses Pharmacologic Actions Micronutrients Growth Substances Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents Antineoplastic Agents Antifibrinolytic Agents Fibrin Modulating Agents Hemostatics |
ClinicalTrials.gov processed this record on June 18, 2013