Dermatitis, AtopicNCT06488742
The Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in Patients With Atopic Dermatitis
A study testing 3% kanuka oil in people with Dermatitis, Atopic and Pruritus, run by Nexgen Dermatologics, Inc. at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 12 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic, Pruritus
- What is being tested?
- 3% kanuka oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Berlin Center
Boynton Beach, Florida, 33437
H G Berlin, ESQ, 561-739-5252, garyberlin17@hotmail.com
Joshua M Berlin, MD
About this study
Official title: 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
Read the 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.
- Conditions
- Dermatitis, Atopic, Pruritus
- Being tested
- 3% kanuka oil
- Medical subject headings
- Dermatitis, Atopic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% kanuka oilOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 3% Kanuka Oil Cream | Experimental | 3% kanuka oil cream will be applied topically to the affected area twice a day for 28 days Receives: Other: 3% kanuka oil |
| 1% Hydrocortisone Cream | Active comparator | 1% Hydrocortisone Cream will be applied topically to the affected area twice a day for 28 days Receives: Other: 3% kanuka oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
ISGA
Investigator scale to determine imporvement in condition
Measured: 28 days
WI-NRS
Scale generated by patient's responses to survey questions to assess improvement in itch
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Nov 2023
- Primary completion10 Dec 2024 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nexgen Dermatologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488742
- Sponsor's protocol ID
- KO-104
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will be confidential and not shared unless authorized by the participant
Publications
Shortt N, Martin A, Kerse K, Shortt G, Vakalalabure I, Barker L, Singer J, Black B, Liu A, Eathorne A, Weatherall M, Rademaker M, Armour M, Beasley R, Semprini A; Medical Research Institute of New Zealand's Pharmacy Research Network. Efficacy of a 3% Kanuka oil cream for the treatment of moderate-to-severe eczema: A single blind randomised vehicle-controlled trial. EClinicalMedicine. 2022 Jul 15;51:101561. doi: 10.1016/j.eclinm.2022.101561. eCollection 2022 Sep.
PubMed 35865740
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in the Treatment of Patients With Mild Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT06488742
- Acronym / sponsor ID
- KO-104
- Conditions
- Dermatitis, Atopic, Pruritus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nexgen Dermatologics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3% Kanuka Oil Cream | Experimental | Other: 3% kanuka oil3% kanuka oil cream will be applied topically to the affected area twice a day for 28 days |
| 1% Hydrocortisone Cream | Active comparator | Other: 3% kanuka oil1% Hydrocortisone Cream will be applied topically to the affected area twice a day for 28 days |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3% kanuka oilTo 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. | Other | 1% Hydrocortisone Cream, 3% Kanuka Oil Cream |
Primary outcome
ISGA
Time frame: 28 days
Investigator scale to determine imporvement in condition
WI-NRS
Time frame: 28 days
Scale generated by patient's responses to survey questions to assess improvement in itch
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Background: PubMed 35865740Shortt N, Martin A, Kerse K, Shortt G, Vakalalabure I, Barker L, Singer J, Black B, Liu A, Eathorne A, Weatherall M, Rademaker M, Armour M, Beasley R, Semprini A; Medical Research Institute of New Zealand's Pharmacy Research Network. Efficacy of a 3% Kanuka oil cream for the treatment of moderate-to-severe eczema: A single blind randomised vehicle-controlled trial. EClinicalMedicine. 2022 Jul 15;51:101561. doi: 10.1016/j.eclinm.2022.101561. eCollection 2022 Sep.
- Individual participant dataSharing planned: No. The individual participant data will be confidential and not shared unless authorized by the participant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3% kanuka oil in people with Dermatitis, Atopic and Pruritus, run by Nexgen Dermatologics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joshua Berlin, MD (561-729-5252, joshberlin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ISGA (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06488742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.