Contact information
Type
Scientific
Primary contact
Prof Hywel Williams
ORCID ID
Contact details
University Hospital
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 8468619
hywel.williams@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 94/48/03
Study information
Scientific title
Identification of the most cost effective, microbiologically safe antimicrobial treatments for acne: a randomised controlled trial
Acronym
Study hypothesis
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.
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: Skin and connective tissue diseases
Intervention
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)
Intervention type
Drug
Phase
Not Specified
Drug names
Antimicrobial
Primary outcome measure
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
Secondary outcome measures
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).
Overall trial start date
03/11/1997
Overall trial end date
02/08/2001
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Participants were 649 people aged 12-39 years, all with mild to moderate inflammatory acne of the face.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
649
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
03/11/1997
Recruitment end date
02/08/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
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
Basic results (scientific)
Publication list
2004 results in https://www.ncbi.nlm.nih.gov/pubmed/15610805
2005 HTA monograph in https://www.ncbi.nlm.nih.gov/pubmed/15588555
Publication citations
-
Results
Ozolins M, Eady EA, Avery AJ, Cunliffe WJ, Po AL, O'Neill C, Simpson NB, Walters CE, Carnegie E, Lewis JB, Dada J, Haynes M, Williams K, Williams HC, Comparison of five antimicrobial regimens for treatment of mild to moderate inflammatory facial acne vulgaris in the community: randomised controlled trial., Lancet, 364, 9452, 2188-2195, doi: 10.1016/S0140-6736(04)17591-0.
-
HTA monograph
Ozolins M, Eady EA, Avery A, Cunliffe WJ, O'Neill C, Simpson NB, Williams HC, Randomised controlled multiple treatment comparison to provide a cost-effectiveness rationale for the selection of antimicrobial therapy in acne., Health Technol Assess, 2005, 9, 1, iii-212.