Condition category
Skin and Connective Tissue Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
18/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D Seukeran

ORCID ID

Contact details

The James Cook University Hospital
Dermatology Department
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0227186079

Study information

Scientific title

Acronym

Study hypothesis

Does the 1450nm diode laser improve inflammatory acne vulgaris? To determine whether the 1450-nm diode laser is effective treatment for facial inflammatory acne vulgaris using a “split-face” randomized controlled trial (one half of the face is treated with the other acting as a control).
1. Primary objective: To determine whether a course of 3 treatments with the 1450-nm diode laser produces a significant difference in acne lesion counts (both inflammatory and non-inflammatory lesions), between the treated and control sides of the face, assessed every 4 weeks after the first treatment by a blinded assessor. 2. Secondary end-points:
2.1 To determine whether the 1450-nm diode laser treatment produces a significant difference in acne as judged using clinical photographs to compare the right and left sides of the face, assessed every 4 weeks after the first treatment by a blinded assessor
2.2 To determine the magnitude of any response to the 1450-nm diode laser treatment using lesion counts to compare the right and left sides of the face
2.3 To determine whether response to acne treatment is modified by other factors such as age, sex, severity or duration of acne
2.4 To determine whether the 1450-nm diode laser produces any adverse effects as determined by the treating doctor, who is not blinded to the treatment allocation
2.5 To determine whether any improvement in the inflammatory acne results in an acceptable cosmetic endpoint for the patient using a simple patient questionnaire
2.6 To determine how long it takes to produce any improvement in inflammatory acne and after how many sessions?
2.7 To determine how long any improvement in acne is maintained for
2.8 To determine what percentage of patients do not achieve a cosmetically acceptable endpoint with laser therapy and who therefore need to proceed to treatment with isotretinoin

Ethics approval

Not provided at time of registration

Study design

Spit-face randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Skin and Connective Tissue Diseases: Acne vulgaris

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

Not provided at time of registration

Overall trial start date

01/10/2005

Overall trial end date

30/10/2007

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

160

Participant 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

Recruitment start date

01/10/2005

Recruitment end date

30/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

South Tees Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21910712

Publication citations

  1. Results

    Darné S, Hiscutt EL, Seukeran DC, Evaluation of the clinical efficacy of the 1,450 nm laser in acne vulgaris: a randomized split-face, investigator-blinded clinical trial., Br. J. Dermatol., 2011, 165, 6, 1256-1262, doi: 10.1111/j.1365-2133.2011.10614.x.

Additional files

Editorial Notes