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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a natural cream with 3% Kanuka Oil (also known as Kunzea Ericoides Oil, White Tea Tree Oil, or White Manuka Oil) can benefit people with eczema, a skin condition that causes itching and irritation. The trial compares the Kanuka Oil cream to a 1% Hydrocortisone cream, a common eczema treatment. Individuals who have had eczema for more than two years and frequently experience severe itching may be suitable for this study. Participants will apply the cream to affected skin twice daily for 28 days. As an unphased trial, this study provides a unique opportunity to explore alternative treatments for eczema.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a cream with 3% kanuka oil was tested for treating eczema. The study compared this cream to a plain cream without active ingredients and found it effective in reducing symptoms like itching. The study reported no major side effects, suggesting the cream is generally safe to use. However, while kanuka oil is known for its germ-fighting properties, limited safety information is available. Although initial results are promising, further research is needed to fully understand its safety for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for eczema, which often include corticosteroids like hydrocortisone creams, 3% Kanuka Oil Cream is derived from the kanuka tree, a natural source. Researchers are excited about this treatment because kanuka oil contains compounds with anti-inflammatory and antimicrobial properties, which may offer a soothing alternative to steroids. This natural approach could reduce the risk of side effects associated with long-term steroid use, making it a promising option for those seeking gentler, plant-based eczema management.

What evidence suggests that this trial's treatments could be effective for eczema?

Research has shown that a cream with 3% kanuka oil can help with eczema, particularly by reducing itchiness. In this trial, participants will receive either the 3% kanuka oil cream or the commonly used 1% hydrocortisone cream. Previous studies found that the kanuka oil cream eased itchiness more effectively than the 1% hydrocortisone cream. This suggests kanuka oil could be a promising natural treatment option. The cream was also tested against a placebo (a cream with no active ingredients) in other studies and showed positive results in improving eczema-related skin conditions. These findings provide some confidence that kanuka oil can help manage eczema symptoms. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1.

thelancet.com

thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00291-7/fulltext

Efficacy of a 3% Kānuka oil cream for the treatment ...

This trial investigated the efficacy and safety of a 3% kānuka oil (KO) cream compared to vehicle control (VC) for the topical treatment of eczema.

2.

medcraveonline.com

medcraveonline.com/JDC/3-kanuka-oil-cream-compared-to-1-hydrocortisone-cream-in-treatment-of-mild-atopic-dermatitis.html

3% Kanuka oil cream compared to 1% hydrocortisone ...

In this study, kanuka oil 3% cream was more effective than hydrocortisone 1% cream in relieving symptoms associated with itch.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35865740/

Efficacy of a 3% Kānuka oil cream for the treatment ...

This trial investigated the efficacy and safety of a 3% kānuka oil (KO) cream compared to vehicle control (VC) for the topical treatment of eczema.

4.

researchgate.net

researchgate.net/publication/362033937_Efficacy_of_a_3_Kanuka_oil_cream_for_the_treatment_of_moderate-to-severe_eczema_A_single_blind_randomised_vehicle-controlled_trial

(PDF) Efficacy of a 3% Kānuka oil cream for the treatment ...

This trial investigated the efficacy and safety of a 3% kānuka oil (KO) cream compared to vehicle control (VC) for the topical treatment of eczema. The trial ...

5.

semanticscholar.org

semanticscholar.org/paper/Efficacy-of-a-3-K%C4%81nuka-oil-cream-for-the-treatment-Shortt-Martin/f7c54e3bb2e2fe2583bceaf3766b9292f74cd5e3

[PDF] Efficacy of a 3% Kānuka oil cream for the treatment ...

Efficacy of a 3% Kānuka oil cream for the treatment of moderate-to-severe eczema: A single blind randomised vehicle-controlled trial · 9 Citations · 56 References.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7694078/

Mānuka Oil—A Review of Antimicrobial and Other ...

This review aimed to collate available evidence on the antimicrobial, anti-parasitic and anti-inflammatory activities of mānuka oil and its components.

7.

withpower.com

withpower.com/trial/phase-pruritus-10-2023-c12c1

Kanuka Oil for Eczema

Kanuka oil has been used traditionally and studied for its antimicrobial properties, but there is limited safety data available.