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

NCT06488742 | Recruiting

• 1 other identifier: KO-104
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dermatitis, Atopic; Pruritus

Outcome Measures

Primary Outcomes (2)

• ISGA

  Investigator scale to determine imporvement in condition

  28 days

• WI-NRS

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

  28 days

Study Arms (2)

3% Kanuka Oil Cream

EXPERIMENTAL

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

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

Other: 3% kanuka oil

Interventions

3% kanuka oil OTHER

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.

1% Hydrocortisone Cream; 3% Kanuka Oil Cream

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nexgen Dermatologics, Inc.: lead

Study Sites (1)

Berlin Center

Boynton Beach, Florida, 33437, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 35865740 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Joshua Berlin, MD

CONTACT

561-729-5252; joshberlin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: November 1, 2023
• Primary Completion: December 10, 2024
• Study Completion: March 20, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)