Identification of the most cost effective, microbiologically safe antimicrobial treatments for acne

ISRCTN	ISRCTN21526350
DOI	https://doi.org/10.1186/ISRCTN21526350
Secondary identifying numbers	HTA 94/48/03

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 04/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hywel Williams
Scientific

University Hospital
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 8468619
Email	hywel.williams@nottingham.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Identification of the most cost effective, microbiologically safe antimicrobial treatments for acne: a randomised controlled trial
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	03/11/1997
Completion date	02/08/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	649
Key inclusion criteria	Participants were 649 people aged 12-39 years, all with mild to moderate inflammatory acne of the face.
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	03/11/1997
Date of final enrolment	02/08/2001

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University Hospital

Nottingham
NG7 2UH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2004		Yes	No
Other publications	HTA monograph	01/01/2005		Yes	No

Editorial Notes

04/10/2017: internal review.
11/01/2008: anticipated end date updated from 2 November 2000 to 2 August 2001.