Identification of the most cost effective, microbiologically safe antimicrobial treatments for acne
| ISRCTN | ISRCTN21526350 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21526350 |
| Protocol serial number | HTA 94/48/03 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University Hospital
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 8468619 |
|---|---|
| hywel.williams@nottingham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Antimicrobial |
| Primary outcome measure(s) |
1. Proportion with at least moderate improvement in patient global self-assessment |
| Key secondary outcome measure(s) |
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). |
| Completion date | 02/08/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
NG7 2UH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
