A preliminary observational study on the effect of pulsed dye laser treatment in patients with facial acne vulgaris.

ISRCTN	ISRCTN73616060
DOI	https://doi.org/10.1186/ISRCTN73616060
Secondary identifying numbers	N0436146535

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 03/10/2013

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr R A Sheehan-Dare
Scientific

Dermatology Department
Brotherton Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom

Phone	+44 (0)113 392 2295
Email	rob.sheehan-dare@leedsth.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	27/01/2004
Completion date	01/04/2006
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	48 in each group
Key inclusion criteria	Patients with mild to moderate facial acne.
Key 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.
Date of first enrolment	27/01/2004
Date of final enrolment	01/04/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Dermatology Department

Leeds
LS1 3EX
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Leeds Teaching Hospitals NHS Trust (UK) NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan