The Efficacy of 3% Kanuka Oil Versus 1% Hydrocortisone Cream in Patients With Atopic Dermatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-75
SponsorNexgen Dermatologics, Inc.
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
3% kanuka oil
Other interventionTo 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: 3% Kanuka Oil CreamExperimental treatment 1 intervention
Group B: 1% Hydrocortisone CreamActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
ISGA
Investigator scale to determine imporvement in condition
Time frame
28 days2
WI-NRS
Scale generated by patient's responses to survey questions to assess improvement in itch
Time frame
28 daysSponsors and contacts
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Source ClinicalTrials.gov