A Study of Topical Arnica & Ledum on Bruise Reduction in HNV
Primary Purpose
Bruise, Contusion
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Arnica montana, Ledum palustre
Sponsored by
About this trial
This is an interventional treatment trial for Bruise, Contusion
Eligibility Criteria
Inclusion Criteria:
- Fitzpatrick skin type 1-3
- BMI 25 kg/m2
- Self described bruisers
- Intact skin in the target area, free of markings, blemishes and hair
Exclusion Criteria:
- Use of recreational drugs, steroids, pain medications, other homeopathic remedies, anticoagulant therapies, antiplatelet therapy
- Known history of dermal sensitivity, serious illness, hematological abnormality, impaired wound healing
- Inability to forego application of topical products in the target area
- Hair removal by laser, wax or chemicals within one week prior to Day 1
- Avoid tanning beds
- History of allergy to topical gels, Arnica or Ledum
- Active wound or infection in the target area
- History of keloids or hypertrophic scarring
- History of collagen or vascular disease
- History of organ transplant
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Placebo
Arm Description
Arnica montana and Ledum palustre infused Pad
Pad (Matching appearance with Active)
Outcomes
Primary Outcome Measures
Efficacy
Time to bruise healing in active vs. placebo
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04533269
Brief Title
A Study of Topical Arnica & Ledum on Bruise Reduction in HNV
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Arnica Montana and Ledum Palustre Formulation on Mechanically Induced Bruising in Healthy Normal Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 31, 2021 (Anticipated)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cearna, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Subjects will have a bruise induced. A pad containing either a placebo or active will be applied to the bruise. Photographs will be taken over the following days to record bruise healing.
Detailed Description
This is a randomized, double-blind, placebo-controlled, crossover, multicenter study that will be used to evaluate the difference in bruise reduction efficacy between active remedy and placebo when a mechanical bruise is induced. The trial will be conducted at 5-8 sites with up to 150 subjects. Each subject will be injured two times using the same bruise-inducing mechanism, and the resulting bruises will be treated with active remedy or placebo-infused pads that will be identical in appearance. Subjects and study investigators will be blinded to the order of treatment assignment. Subjects will be asked to come to the clinic for photographic assessments of the bruise. Each subject will be randomly assigned to have a placebo or active remedy pad applied over each mechanically induced bruise on Day 1. The pad will be applied by study staff immediately after bruise induction (within 5 minutes). The pad will cover the bruised area completely, and then sealed with Tegaderm. All procedures, including bruise induction, treatment, and photography, will be administered by study staff who are blinded to treatment type. All photographs will be rated according to standardized criteria by blinded, trained study investigators after the completion of all subject data collection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruise, Contusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Treatment kits will be coded. An unblinded statistician will provide the treatment codes after the study database is locked.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
Arnica montana and Ledum palustre infused Pad
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Pad (Matching appearance with Active)
Intervention Type
Other
Intervention Name(s)
Arnica montana, Ledum palustre
Intervention Description
Homeopathic
Primary Outcome Measure Information:
Title
Efficacy
Description
Time to bruise healing in active vs. placebo
Time Frame
11 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Fitzpatrick skin type 1-3
BMI 25 kg/m2
Self described bruisers
Intact skin in the target area, free of markings, blemishes and hair
Exclusion Criteria:
Use of recreational drugs, steroids, pain medications, other homeopathic remedies, anticoagulant therapies, antiplatelet therapy
Known history of dermal sensitivity, serious illness, hematological abnormality, impaired wound healing
Inability to forego application of topical products in the target area
Hair removal by laser, wax or chemicals within one week prior to Day 1
Avoid tanning beds
History of allergy to topical gels, Arnica or Ledum
Active wound or infection in the target area
History of keloids or hypertrophic scarring
History of collagen or vascular disease
History of organ transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacqueline Blem
Phone
858-945-6456
Email
jacqui@cardiffclinical.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate data will be shared and published.
Learn more about this trial
A Study of Topical Arnica & Ledum on Bruise Reduction in HNV
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