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ISRCTN
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ISRCTN21526350
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ClinicalTrials.gov identifier
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Public title
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Identification of the most cost effective, microbiologically safe antimicrobial treatments for acne
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 94/48/03
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Study hypothesis
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The aims of this study are to assess the relative clinical efficacy of the currently available oral and topical antimicrobial therapies for acne vulgaris and to compare their potential to promote or prevent the emergence of antibiotic resistance in Propionibacterium acnes, the organism implicated in the development of inflamed lesions. At present selection of therapy for individual patients is largely random and there is no convincing evidence in the literature for the superiority of specific agents. There is a bias towards the use of more expensive drugs without adequate justification. Given the prevalence of acne and the long duration of the disease, there is much scope to reduce the cost of therapy without compromising therapeutic efficacy or safety. In order to achieve this a pharmaceutical industry-independent randomised controlled parallel group study in general practice is proposed.
As well as identifying the most active and cost effective therapies the study will also provide a detailed comparison of the clinical and microbiological safety profiles of the products tested.
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Skin and connective tissue diseases: Skin and connective tissue diseases
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Participants - inclusion criteria
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Participants were 649 people aged 12-39 years, all with mild to moderate inflammatory acne of the face.
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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03/11/1997
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Anticipated end date
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02/08/2001
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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649
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Interventions
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Please note that, as of 11 January 2008, the anticipated end date of this trial has been updated from 2 November 2000 to 2 August 2001.
Interventions:
In this randomised, observer-masked trial, 649 community participants were allocated one of five antibacterial regimens. There were 649 participants in the main 5 treatment groups (+112 on 6 treatments discontinued early in the trial due to slow recruitment).
1. 500 mg oral oxytetracycline (non-proprietary) b.d. + topical vehicle control b.d.
2. 100 mg oral Minocin MR® (minocycline) o.d. + topical vehicle control b.d.
3. Topical Benzamycin® ( 3% erythromycin + 5% benzoyl peroxide) b.d. + oral placebo o.d.
4. Topical Stiemycin® (2% erythromycin) o.d. + topical Panoxyl® Aquagel (5% benzoyl peroxide) o.d. + oral placebo o.d.
5. Topical Panoxyl® Aquagel (5% benzoyl peroxide) b.d. + oral placebo o.d. (the active comparator group)
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Primary outcome measure(s)
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1. Proportion with at least moderate improvement in patient global self-assessment
2. Change in inflamed lesion count, both at 18 weeks from start of treatment
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Secondary outcome measure(s)
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The Burke and Cunliffe grade, assessor global assessment of the participant, a new acne severity score (combined assessment of inflamed lesions, non-inflamed lesions & redness of face.), the Short-Form 36 questionnaire, the Dermatology Life Quality Index, the Dermatology Quality of Life questionnaire, local irritation (assessed by both participant and assessor and indirectly by use of moisturisers), the proportion of participants for whom the worst aspect of their acne had improved, re-referral rates after treatment completion, other adverse events and drop out rates, bacterial skin colonisation (with propionibacteria resistant to erythromycin, clindamycin or the tetracyclines estimated at baseline and all subsequent on treatment visits using a semi-quantitative scoring method to derive data on both prevalence and population density).
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15610805
2005 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15588555
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Contact name
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Prof
Hywel
Williams
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Address
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University Hospital
Queen's Medical Centre
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Tel
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+44 (0)115 8468619
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Fax
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+44 (0)115 8468618
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Email
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hywel.williams@nottingham.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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27/08/2009
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Date ISRCTN assigned
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25/04/2003
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