A preliminary observational study on the effect of pulsed dye laser treatment in patients with facial acne vulgaris.
ISRCTN | ISRCTN73616060 |
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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
Scientific
Dermatology Department
Brotherton Wing
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
Phone | +44 (0)113 392 2295 |
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rob.sheehan-dare@leedsth.nhs.uk |
Study information
Study design | Randomised controlled trial |
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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 |
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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
LS1 3EX
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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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 |