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 |
| Protocol serial number | N0436146535 |
| Sponsor | Department of Health |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) NHS R&D Support Funding |
- 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 |
|---|---|
| rob.sheehan-dare@leedsth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Following treatments given at week 0 and week 4: |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| 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 sample size at registration | 96 |
| 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
- United Kingdom
- England
Study participating centre
Dermatology Department
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
