The Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in Patients With Atopic Dermatitis

June 28, 2024 updated by: Nexgen Dermatologics, Inc.

Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in the Treatment of Patients With Mild Atopic Dermatitis

Atopic dermatitis is a common disease affecting millions worldwide. A common associated symptom in this population is pruritus. We seek to investigate the use of an natural, over-the-counter cosmeceutical to help this population

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There are many treatment options available for atopic dermatitis yet many patients still suffer from the underlying symptomatology. It is important to explore other treatment alternatives to help this population.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Boynton Beach, Florida, United States, 33437
        • Recruiting
        • Berlin Center
        • Contact:
        • Principal Investigator:
          • Joshua M Berlin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • age greater than 12 years, diagnosis of atopic dermatitis for longer than 2 years, investigator's static global assessment score of either 2 or 3, and initial worst itch numerical rating scale (WI-NRS) for itch greater than 4.

Exclusion Criteria:

  • the use of topical or systemic corticosteroids within 28 days of entering the study, the use of any other non-emollient therapy within 28 days of entering the study,nursing, and pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3% Kanuka Oil Cream
3% kanuka oil cream will be applied topically to the affected area twice a day for 28 days
Other: 3% kanuka oil
To assess the efficacy in patients with mild atopic dermatitis, 3% kanuka oil will be applied twice a day for 28 days. 3% kanuka oil is a naturally occurring extract from the kanuka tree and is considered an over-the-counter agent.
Active Comparator: 1% Hydrocortisone Cream
1% Hydrocortisone Cream will be applied topically to the affected area twice a day for 28 days
Other: 3% kanuka oil
To assess the efficacy in patients with mild atopic dermatitis, 3% kanuka oil will be applied twice a day for 28 days. 3% kanuka oil is a naturally occurring extract from the kanuka tree and is considered an over-the-counter agent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ISGA
Time Frame: 28 days
Investigator scale to determine imporvement in condition
28 days
WI-NRS
Time Frame: 28 days
Scale generated by patient's responses to survey questions to assess improvement in itch
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nexgen Dermatologics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

December 10, 2024

Study Completion (Estimated)

March 20, 2025

Study Registration Dates

First Submitted

June 28, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 5, 2024

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KO-104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data will be confidential and not shared unless authorized by the participant

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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