3% Kanuka Oil Serum for the Topical Treatment of Acne

Phase 2

Completed

• Conditions: Acne Vulgaris; Skin - Dermatological conditions

• Registration Number: ACTRN12619001744145
• Lead Sponsor: Hikurangi Bioactives Limited Partnership

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-09
• Study Completion: 2022-06-21
• Last Update Posted: 28 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in DLQI scores[Week 12 post baseline]