A Study of Topical Arnica & Ledum on Bruise Reduction in HNV

A Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Arnica Montana and Ledum Palustre Formulation on Mechanically Induced Bruising in Healthy Normal Volunteers

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.

Study Overview

• Status: Unknown
• Conditions: Bruise, Contusion
• Intervention / Treatment: Other: Arnica montana, Ledum palustre

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; Arnica montana and Ledum palustre infused Pad	Other: Arnica montana, Ledum palustre; Homeopathic
Placebo Comparator: Placebo; Pad (Matching appearance with Active)	Other: Arnica montana, Ledum palustre; Homeopathic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy	Time to bruise healing in active vs. placebo	11 days

Collaborators and Investigators

• Sponsor: Cearna, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 31, 2021
• Primary Completion (Anticipated): October 31, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Wounds, Nonpenetrating; Contusions
• Other Study ID Numbers: CI-B001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Aggregate data will be shared and published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No