Skin and Connective Tissue Diseases: Acne vulgaris Skin and Connective Tissue Diseases Acne vulgaris
Conditions
Interventions
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.
Sponsors
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Eligibility
Inclusion criteria
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 envelope system will be used to ensure that the next treatment allocation is not known, when a patient is being recruited for the study. At no point will the assessors be aware of which side of the face has been treated. The patient and the person performing the treatment will be aware of which side of the face is being treated. It is felt by the study investigators that if fewer than one third of treated patients obtain any benefit from laser treatment then the treatment will not be of any real clinical value. One third of treated patients obtaining some clinical benefit is equivalent to 67% of patients having the treated side scored as the better side (as 50% would be expected to have fewer lesions on the treated side if the treatment had no benefit at all). To achieve 80% power to show a statistically significant difference (with 95% confidence) in the number of patients for whom the laser-treated side of the face is scored as better than the control side, if the laser treated side is better in at least 67% of patients would require 142 patients. We will recruit 160 patients to allow for 18 subjects not to complete the 12 week assessment and to still have 142 patients in the final analysis.
Exclusion criteria
Exclusion criteria: 1. Less than 16 years of age 2. Female patients who are pregnant or breastfeeding (or who are attempting to become pregnant) 3. Patients in whom systemic treatment with isotretinoin is indicated 4. Patients with a history of hypertrophic or keloid scarring 5. The use of dermal fillers in the previous 3 months 6. Patients with facial hair eg beard or moustache in whom assessment will be difficult
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed