Kanuka Oil for Eczema

Overseen By Joshua Berlin, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nexgen Dermatologics, Inc.

Must not be taking: Corticosteroids, Non-emollient therapies

Disqualifiers: Nursing, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

60 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

You will need to stop using topical or systemic corticosteroids and any other non-emollient therapies at least 28 days before joining the study.

What data supports the effectiveness of the treatment Kanuka Oil for Eczema?

Research shows that kanuka oil has anti-inflammatory and antibacterial properties, which can help reduce skin inflammation and fight bacteria, potentially benefiting eczema treatment. ^{1 2 3 4 5}

Is Kanuka oil safe for use in humans?

Kanuka oil has been used traditionally and studied for its antimicrobial properties, but there is limited safety data available. Some studies suggest caution due to variability in oil composition and potential effects on muscle contractions, which could be concerning during childbirth. ^{1 3 4 5 6}

How is the kanuka oil treatment for eczema different from other treatments?

Kanuka oil treatment for eczema is unique because it uses a natural oil with anti-inflammatory and antibacterial properties, traditionally used by the Māori people of New Zealand. This makes it different from other treatments that may rely on synthetic ingredients or steroids. ^{1 4 5 6 7}

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for individuals over 12 years old who have had atopic dermatitis (eczema) for more than two years and are experiencing significant itching. Participants must not have used non-emollient therapies or corticosteroids in the past 28 days, and cannot be pregnant or nursing.

Inclusion Criteria

My worst itch score is more than 4.

Investigator's static global assessment score of either 2 or 3

I am older than 12 years.

Exclusion Criteria

I haven't used any non-moisturizing treatments in the last 28 days.

Nursing

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply either 3% Kanuka Oil Cream or 1% Hydrocortisone Cream topically to the affected area twice a day

4 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 3% Kanuka Oil

Trial Overview The study is testing the effectiveness of a natural product, 3% kanuka oil, compared to a standard treatment, 1% hydrocortisone cream, in reducing itchiness associated with atopic dermatitis.

Participant Groups

Group I: 3% Kanuka Oil Cream Experimental Treatment 1 Intervention

3% kanuka oil cream will be applied topically to the affected area twice a day for 28 days

Group II: 1% Hydrocortisone Cream Active Control 1 Intervention

1% Hydrocortisone Cream will be applied topically to the affected area twice a day for 28 days

Who Is Running the Clinical Trial?

Nexgen Dermatologics, Inc.

Lead Sponsor

Trials

3

Recruited

200+

Findings from Research

The study identified that commercial manuka oil contains predominantly sesquiterpene hydrocarbons (over 60%) and has significant antimicrobial activity linked to specific triketones, including some that were previously unreported.

Kanuka oil is characterized by high levels of alpha-pinene (over 50%), and the study found that simple measurements like density can help differentiate between commercial and non-commercial oils, as well as predict their antimicrobial effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chemical, physical and antimicrobial properties of essential oils of Leptospermum scoparium and Kunzea ericoides. Porter, NG., Wilkins, AL.[2019]

In a study involving 123 patients with atopic eczema, evening primrose oil supplementation did not show any significant improvement in skin symptoms such as redness, scaling, or overall severity of the condition.

The study utilized a double-blind, blocked crossover design, indicating a rigorous approach to testing the efficacy of evening primrose oil, but ultimately found no beneficial effects at doses of 2-8 grams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Atopic eczema unresponsive to evening primrose oil (linoleic and gamma-linolenic acids). Bamford, JT., Gibson, RW., Renier, CM.[2022]

The three 'tea-tree' essential oils (Melaleuca, Manuka, and Kanuka) exhibit different pharmacological effects, with Manuka showing spasmolytic action and Melaleuca and Kanuka displaying spasmogenic effects on smooth muscle, indicating their varied potential therapeutic uses.

Caution is advised when using these essential oils, especially during childbirth, as they can decrease uterine contractions, posing risks to both mother and baby, and their toxicity has not been thoroughly tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological and antimicrobial studies on different tea-tree oils (Melaleuca alternifolia, Leptospermum scoparium or Manuka and Kunzea ericoides or Kanuka), originating in Australia and New Zealand. Lis-Balchin, M., Hart, SL., Deans, SG.[2019]

A 3% kānuka oil cream significantly improved eczema symptoms in adults compared to a vehicle control, with a mean difference in Patient Orientated Eczema Measure (POEM) scores of -3.1, indicating better efficacy of the kānuka oil treatment.

The treatment was found to be safe and well-tolerated, with similar rates of adverse events between the kānuka oil group and the control group, suggesting it is a viable option for managing moderate-to-severe eczema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a 3% Kānuka oil cream for the treatment of moderate-to-severe eczema: A single blind randomised vehicle-controlled trial. Shortt, N., Martin, A., Kerse, K., et al.[2022]

Australian tea tree oil demonstrated the strongest overall antibacterial and antifungal activity among the oils tested, indicating its potential as a broad-spectrum antimicrobial agent.

Manuka oil, particularly due to its beta-triketone content, was most effective against Gram-positive bacteria and dermatophytes, highlighting its specific therapeutic potential in treating certain infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of the in vitro antimicrobial activity of tea tree oils s.l. with special reference to the activity of beta-triketones. Christoph, F., Kaulfers, PM., Stahl-Biskup, E.[2022]

Essential oils from kanuka and manuka significantly inhibited the growth of common bacteria and fungi, demonstrating minimum inhibitory concentrations as low as 0.78%, indicating their potential as effective antimicrobial agents.

Both essential oils reduced the release of inflammatory cytokines in human immune cells without negatively impacting the immune system, suggesting their dual role in treating infections and inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigations of kanuka and manuka essential oils for in vitro treatment of disease and cellular inflammation caused by infectious microorganisms. Chen, CC., Yan, SH., Yen, MY., et al.[2018]

A post-marketing surveillance study involving over 3500 pediatric patients showed that a bath oil containing soya oil and lauromacrogols is effective and well-tolerated for treating dry and itchy skin, particularly atopic eczema, with a significant reduction in symptom scores from 7.21 to 2.71 over an average treatment duration of 42 days.

The treatment was rated as 'very good' or 'good' in terms of efficacy by 89.4% of physicians, and it helped reduce the need for steroid treatments in nearly 60% of patients, highlighting its potential benefits in managing eczema while minimizing steroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating dry skin and pruritus with a bath oil containing soya oil and lauromacrogols. Bettzuege-Pfaff, BI., Melzer, A.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Chemical, physical and antimicrobial properties of essential oils of Leptospermum scoparium and Kunzea ericoides. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Atopic eczema unresponsive to evening primrose oil (linoleic and gamma-linolenic acids). [2022]

3. England pubmed.ncbi.nlm.nih.gov

Pharmacological and antimicrobial studies on different tea-tree oils (Melaleuca alternifolia, Leptospermum scoparium or Manuka and Kunzea ericoides or Kanuka), originating in Australia and New Zealand. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of a 3% Kānuka oil cream for the treatment of moderate-to-severe eczema: A single blind randomised vehicle-controlled trial. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

A comparative study of the in vitro antimicrobial activity of tea tree oils s.l. with special reference to the activity of beta-triketones. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Investigations of kanuka and manuka essential oils for in vitro treatment of disease and cellular inflammation caused by infectious microorganisms. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Treating dry skin and pruritus with a bath oil containing soya oil and lauromacrogols. [2018]