CompletedPhase 2ACTRN12614000003673

A single-blind randomised controlled trial of topical Kanuka honey for the treatment of Acne

In adult patients with Acne will topical medical grade Kanuka honey, in addition to washing with Protex Soap Fresh Antibacterial, reduce acne severity compared with washing with Protex Soap Fresh Antibacterial alone.


Sponsor

Honeylab Ltd

Enrollment

138 participants

Start Date

Feb 4, 2014

Study Type

Interventional

Conditions

Summary

A recent pilot study using a Kanuka honey product for Acne showed that over 80% of participants self reported improvement, therefore this study treatment has the potential to be an effective treatment for Acne symptoms. In this study 138 adults with Acne will either wash their face with Protex Soap Fresh Antibacterial alone twice daily, or apply topical Kanuka honey to areas of Acne on their face for 30-60 minutes twice a day prior to washing with Protex Soap Fresh Antibacterial for 12 weeks. At baseline and after 4 weeks and 12 weeks the patient's Acne will be assessed to look at changes in severity. Participants will complete a diary for 12 weeks to record their daily treatment applications and weekly severity assessment. Subjects will complete a Dermatology Quality of Life questionnaire at all visits, to note any changes in quality of life. A visual analogue scale will be completed to note any improvement or worsening of a patient's Acne at Visits 2 and 3. This study will investigate the effectiveness of Kanuka honey in treating Acne, potentially improving the health outcomes of those with the condition, and will contribute to the knowledge base around the use of honey for the treatment of skin conditions.


Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 40 Yearss

Inclusion Criteria2

  • Aged 16-40 years at the time of enrolment
  • Baseline facial IGA (investigator Global Assessment) of 2 or greater

Exclusion Criteria7

  • Any significant systemic illness
  • Current requirement for systemic corticosteroid or has had systemic corticosteroid in the 4 weeks prior to Visit 1 Current requirement for oral antibiotic treatment for acne, or has had oral antibiotic treatment for acne in the 4 weeks prior to Visit 1
  • Current requirement for topical corticosteroid or topical antibiotics for the treatment of acne
  • Change in oral contraceptive therapy in the last 3 months
  • A systemic retinoid in the 2 months prior to Visit 1
  • Known or suspected allergy to honey, or Protex Soap Fresh Antibacterial
  • Any other condition which, at the investigators discretion, it is believed may present a safety risk or impact the feasibility of the study or the study results

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Interventions

Topical medical grade Kanuka honey with 10% glycerin content applied to the affected facial area twice daily for 30-60 minutes per application, for twelve weeks. Patients will then wash area with Pro

Topical medical grade Kanuka honey with 10% glycerin content applied to the affected facial area twice daily for 30-60 minutes per application, for twelve weeks. Patients will then wash area with Protex Soap Fresh Antibacterial medicated soap as per manufacturer's instructions, twice daily after honey treatment. A patient diary will record applications during the treatment period.


Locations(1)

New Zealand

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ACTRN12614000003673


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