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RecruitingNCT06488742Updated Jul 5, 2024

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

An interventional study of 3% kanuka oil in Dermatitis, Atopic and Pruritus, sponsored by Nexgen Dermatologics, Inc.. Recruiting at 1 site in United States. Open to participants aged 12 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by Nexgen Dermatologics, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled Nov 2023, registered Jun 2024).
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Dermatitis, Atopic
  • Pruritus
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's planned enrollment of 60 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Nexgen Dermatologics, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Other3% 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.

06

What researchers measure

Primary outcomes

  1. ISGA

    Investigator scale to determine imporvement in condition

    Time frame: 28 days

  2. WI-NRS

    Scale generated by patient's responses to survey questions to assess improvement in itch

    Time frame: 28 days

07

Study locations

1 of 1 sites recruiting
  • Berlin Center
    Boynton Beach, Florida 33437, United States
    Recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No — The individual participant data will be confidential and not shared unless authorized by the participant

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06488742
Lead sponsor
Nexgen Dermatologics, Inc.
Responsible party
Sponsor
First posted
Jul 5, 2024
Start date
Nov 1, 2023
Primary completion
Dec 10, 2024 (estimated)
Completion
Mar 20, 2025 (estimated)
Last update
Jul 5, 2024

Study contacts

Joshua Berlin, MD
Contact
joshberlin@hotmail.com
561-729-5252

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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