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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesAcne 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) studiedSkin and Connective Tissue Diseases: Acne vulgaris
InterventionPulsed dye laser treatment vs standard practice

Added 03/10/2013: This trial was stopped in January 2006 due to poor recruitment.
Intervention typeOther
Primary outcome measureFollowing 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 measuresNot provided at time of registration
Overall study start date27/01/2004
Completion date01/04/2006
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants48 in each group
Key inclusion criteriaPatients with mild to moderate facial acne.
Key exclusion criteriaPatients 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 enrolment27/01/2004
Date of final enrolment01/04/2006

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan