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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
Cearna, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bruise, Contusion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 24, 2020
    Last Updated
    January 6, 2021
    Sponsor
    Cearna, Inc.
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    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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