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

Sponsor

Cearna, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04533269

Collaborator

(none)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bruise, Contusion	Other: Arnica montana, Ledum palustre	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Treatment kits will be coded. An unblinded statistician will provide the treatment codes after the study database is locked.

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jul 31, 2021

Anticipated Primary Completion Date :

Oct 31, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Efficacy [11 days]
Time to bruise healing in active vs. placebo

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cearna, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cearna, Inc.

ClinicalTrials.gov Identifier:

NCT04533269

Other Study ID Numbers:

CI-B001

First Posted:

Aug 31, 2020

Last Update Posted:

Jan 8, 2021

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Contusions

Study Results

No Results Posted as of Jan 8, 2021