1450nm Smoothbeam diode laser in inflammatory acne vulgaris - a split-face randomised controlled trial.

INTERVENTION: A fixed weekly period or session will be dedicated to recruit and review study participants. Other appointment times will be arranged at the convenience of patients unable to attend the fixed session. 1. Initial assessment 1.1 Consideration for eligibility for inclusion: selection criteria 1.2 Detailed verbal and written information on study purpose, design and patient input with the opportunity to address patient questions. Explanation of the study laser and side effects 1.3 Obtain written informed consent 1.4 Current acne treatment and date of commencement documented 1.5 Patient?s general practitioner informed of patients entry into the study. 2. First treatment (week 0) 2.1 Address any outstanding issues 2.2 Assessment with lesion counts (Revised Leeds acne grading) of both sides of the face. Clinical photographs taken 2.3 Assign patient study number and give patient sealed envelope stating the side of face to be treated 2.4 Patient takes envelope to person performing treatment in laser clinic 2.5 Patient receives first treatment 3 Assessment and second treatment (week 4) Assessor: 3.1 Assess acne on both sides of the face with lesion counts (Revised Leeds acne grading) 3.2 Take clinical photographs (before treatment) Person giving treatment: 3.3 Note any adverse effects from previous treatment 3.4 Treat allocated side of the face 3.5 Patient satisfaction questionnaire 4 Assessment and third treatment (week 8) As for 3.5, post‐treatment assessment every 4 weeks Assessment every 4 weeks with lesion counts (Revised Leeds acne grading) and clinical photographs up until 12 months post treatment or withdrawal from the study. GP informed at completion of the study. Clinical photographs assessed by dermatologists blinded as to which side of the face was treated. CONDITION: Skin and Connective Tissue Diseases: Acne vulgaris ; Skin and Connective Tissue Diseases ; Acne vulgaris PRIMARY OUTCOME: 1. Change in lesion counts (Revised Leeds acne grading) comparing the side of face treated with the untreated side; 2. Change in clinical photographs as assessed by consultant dermatologists blinded as to which side of the face was treated. SECONDARY OUTCOME: Not provided at time of registration INCLUSION CRITERIA: Support from Dr. R. Bellamy ‐ Trust advisor on statistics. INCLUSION CRITERIA: patients with mild or moderate acne vulgaris who have not had a cosmetically acceptable response to their current treatment. This treatment may include any topical treatment or systemic antibiotics or hormonal treatment or no treatment. We aim to recruit patients from the Dermatology outpatient department at The James Cook University Hospital. Identified patients will then be referred to a dedicated clinic led by the principal investigator. At the study clinic the patient will be informed of the study design and objectives. Written information will be provided and any questions addressed. The patient will be invited to participate and written consent obtained. The patient will have as long as he or she requires to decide whether or not to enter the study. Randomisation will be performed by a statistician who is not involved in the running of the study. A sealed envel