Condition category
Skin and Connective Tissue Diseases
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
03/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes