Feasibility Study of 3% Kanuka Oil Serum vs Vehicle Control for the Topical Treatment of Facial Acne Vulgaris

Hikurangi Bioactives Limited Partnership0 个研究点目标入组 30 人开始时间: 2019年12月9日最近更新: 2022年11月28日

适应症

试验速览

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•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.

•- 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.

发起方

Hikurangi Bioactives Limited Partnership