None listed
Conditions
Brief summary
This study will assess the efficacy of 3% Kanuka Oil serum in the treatment of acne. The study is designed as a double blind, randomised, vehicle controlled study. Thirty participants will be recruited via pharmacies throughout New Zealand and will be randomised 1:1 to receive either 3% Kanuka Oil serum or vehicle control. The vehicle control is the same serum just without the Kanuka Oil.
Interventions
3% Kanuka Oil Serum
Applied topically, twice daily, for 12 weeks.
Participants are recommended to apply the treatment liberally to the affected areas.
A weekly participant diary will be used to monitor adherence.
Sponsors
Hikurangi Bioactives Limited Partnership
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
• Participant has the ability and willingness to sign a written informed consent using a digital signature or paper form if back up is required. • Participant is aged between 18 and 50 years of age, inclusive. • Participant reported, Physician diagnosis of acne vulgaris. • A minimum of 10 inflammatory/non-inflammatory acne lesions on the face. • A minimum CADI score of greater than or equal to 1. • A minimum IGA score of greater than or equal to 2. • Participant is willing to stop current acne treatments. • Participant is willing to replace their facewash/cleanser with a facial cleanser (Cetaphil) as supplied at enrolment. • Participant is able and willing to attend the follow up visits during the visit windows. • Participant is able and willing to complete the study and to comply with all study instructions.
Exclusion criteria
- Severity of acne requiring any systemic therapy including isotretinoin, systemic antibiotics, or hormonal therapies. - Use of the following anti acne treatments: topical acne medication in the last two weeks; systemic antibiotics in the last four weeks; systemic retinoids in the last 12 weeks. - Participant has a current requirement for hormonal therapy, unless they have been on a stable dose for eight weeks or longer. - Participant has any inflammatory skin condition of the face other than acne vulgaris. - Participant has an active skin or systemic infection - Participant with history of known or suspected allergy or intolerance to Kunzea Robusta (Kanuka) Oil, Glycerine, Simmondsia Chinensis (Jojoba) Oil, Sclerotium Gum, Benzyl alcohol or Dehydroacetic Acid. - Participant has facial hair that would interfere with acne assessment. - Participant wears cosmetics that would interfere with acne assessment. - Participant is pregnant or planning to become pregnant during the study. - Participation in a clinical trial involving an investigational product during the last three months. - Any other condition which, at the investigators’ discretion, it is believed may present a safety risk or impact upon the ability of the participant to complete the study.
Outcome results
None listed