Condition category
Skin and Connective Tissue Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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)

Intervention type

Drug

Phase

Not Specified

Drug names

Antimicrobial

Primary outcome measures

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

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

http://www.dh.gov.uk/en/index.htm

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

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15610805
2005 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15588555

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes