Recruiting

Kanuka Oil vs. Hydrocortisone

Sponsor:

Nexgen Dermatologics, Inc.

Code:

NCT06488742

Conditions

Dermatitis, Atopic

Pruritus

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Accepted

Interventions

3% kanuka oil

Study Details

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

Study ID

NCT06488742

Start date

Nov 1, 2023

Status verified date

Jun, 2024

Completion date

Mar 20, 2025

Anticipated

Primary completion date

Dec 10, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Accepted

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:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 3% Kanuka Oil Cream

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

active comparator: 1% Hydrocortisone Cream

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

Interventions

3% 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.

Primary outcome measure

  • ISGA [ Time Frame: 28 days ]
  • WI-NRS [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Joshua Berlin, MD

561-729-5252joshberlin@hotmail.com

Locations

Berlin Center

Recruiting

Boynton Beach, Florida, United States, 33437

Contacts

H G Berlin, ESQ

561-739-5252garyberlin17@hotmail.com

Principal Investigator:

Joshua M Berlin, MD

More Information

Sponsor

Nexgen Dermatologics, Inc.

Last update posted

Jul 5, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nexgen Dermatologics, Inc. on 2024-07-05.