Efficacy of a 3% Kānuka oil cream for the treatment of moderate-to-severe eczema: A single blind randomised vehicle-controlled trial.
Nicholas Shortt, Alexander Martin, Kyley Kerse...
https://pubmed.ncbi.nlm.nih.gov/35865740Actively Recruiting
Phase Not Applicable
Age: 12Years - 75Years
All Genders
Healthy Volunteers
ID06488742
Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in the Treatment of Patients With Mild Atopic Dermatitis
Led by Nexgen Dermatologics, Inc. · Updated on 2024-07-05
60
Participants Needed
1
Research Sites
14 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Atopic dermatitis is a widespread condition affecting millions of people worldwide, often accompanied by intense itching known as pruritus. Researchers are exploring alternative treatments to help those with this condition, focusing on comparing a natural, over-the-counter product with a common steroid cream. This study evaluates the effects of 3% kanuka oil compared to 1% hydrocortisone cream in patients with mild atopic dermatitis. Participants will be randomly assigned to one of two groups. One group will apply 3% kanuka oil cream to affected skin areas twice daily for 28 days, while the other group will use 1% hydrocortisone cream twice daily for the same duration. The study is carefully designed to compare these treatments under controlled conditions, including masking to reduce bias. During the study, participants will be monitored through assessments such as the Investigator's Static Global Assessment (ISGA) and the Worst Itch Numerical Rating Scale (WI-NRS) over 28 days. Researchers will evaluate changes in skin condition and itching severity. The total study period includes regular evaluations to track response and safety, with participation lasting about one month.
CONDITIONS
Brief Title
The Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in Patients With Atopic Dermatitis
Who Can Participate
Age: 12Years - 75Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Age greater than 12 years
- Diagnosis of atopic dermatitis for longer than 2 years
- Investigator's static global assessment score of 2 or 3
- Initial worst itch numerical rating scale (WI-NRS) for itch greater than 4
You will not qualify if you...
- Use of topical or systemic corticosteroids within 28 days before entering the study
- Use of any other non-emollient therapy within 28 days before entering the study
- Current nursing
- Pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 28 days
Participants apply either 3% kanuka oil cream or 1% hydrocortisone cream topically to the affected area twice a day for 28 days to assess treatment efficacy.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Berlin Center
Boynton Beach, Florida, United States, 33437
Actively Recruiting
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Research Team
J
Joshua Berlin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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