Contact information
Type
Scientific
Primary contact
Dr R A Sheehan-Dare
ORCID ID
Contact details
Dermatology Department
Brotherton Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 2295
rob.sheehan-dare@leedsth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436146535
Study information
Scientific title
Acronym
Study hypothesis
Acne patients are increasingly developing clinically significant antibiotic resistant propionbacterium acnes resulting in the reduced effect of antibiotic therapy. Therefore, there is a need to develop non-antibiotic treatment options. A small study has shown benefit from treatment with a short pulse width 0.35 msec low energy pulsed dye laser used as monotherapy. Due to the expense of this type of treatment, it is important to determine the value of pulsed dye laser treatment as adjuvant therapy in patients receiving conventional antibiotic therapy. Most pulsed dye lasers use a longer 1.5 msec pulse width and the effect of this type of laser as adjuvant therapy for acne also needs to be determined. Therefore the aim of this study is to assess the effect of both an N-lite low energy pulsed.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Skin and Connective Tissue Diseases: Acne vulgaris
Intervention
Pulsed dye laser treatment vs standard practice
Added 03/10/2013: This trial was stopped in January 2006 due to poor recruitment.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Following treatments given at week 0 and week 4:
1. Reduction in inflamed acne lesion counts
2. Reduction in overall acne grade, non-inflamed acne lesion counts, and total acne lesion counts
Secondary outcome measures
Not provided at time of registration
Overall trial start date
27/01/2004
Overall trial end date
01/04/2006
Reason abandoned
Participant recruitment issue
Eligibility
Participant inclusion criteria
Patients with mild to moderate facial acne.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
48 in each group
Participant exclusion criteria
Patients with acne conglobata, acne fulminans and secondary care, with underlying diseases or other dermatological conditions that require the use of interfering topical therapy, with photosensitive disorders.
Recruitment start date
27/01/2004
Recruitment end date
01/04/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Dermatology Department
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching Hospitals NHS Trust (UK) NHS R&D Support Funding
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