Condition category
Skin and Connective Tissue Diseases
Date applied
09/09/2005
Date assigned
06/10/2005
Last edited
01/08/2012
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

Dr Norma Kellett

ORCID ID

Contact details

Inveresk Research International
Elphinstone Research Centre
Tranent
EH33 2NE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZCG/38/C

Study information

Scientific title

Acronym

Study hypothesis

To assess the patient acceptability of Zindaclin® when compared to other marketed topical antibiotics.

Ethics approval

Not provided at time of registration

Study design

Randomised active controlled crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Mild to moderate acne vulgaris.

Intervention

1. Zindaclin® once daily
2. Benzamycin® twice daily
3. Zineryt® twice daily
4. Dalacin-T® Topical Lotion twice daily

Intervention type

Drug

Phase

Phase IV

Drug names

Zindaclin®, Benzamycin®, Zineryt®, Dalacin-T®

Primary outcome measures

Patient Acceptability Questionnaire assessing the four study products.

Secondary outcome measures

1. A conjoint analysis assessment of product preferences
2. The level of product use

Overall trial start date

20/02/2002

Overall trial end date

09/10/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Male and female patients aged between 16 and 40 years with mild to moderate acne graded between 1.0 and 7.0 on the Leeds Revised Acne Grading System, 1998.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

65

Participant exclusion criteria

1. Patients with acne conglobata, acne fulminans, sandpaper acne, submarine comedonal acne or secondary acne were excluded
2. The use of topical or systemic antibiotics or topical antimicrobials within the previous week was disallowed

Recruitment start date

20/02/2002

Recruitment end date

09/10/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Inveresk Research International
Tranent
EH33 2NE
United Kingdom

Sponsor information

Organisation

ProStrakan Pharmaceuticals (UK)

Sponsor details

Buckholm Mill Brae
Galashiels
TD1 2HB
United Kingdom

Sponsor type

Industry

Website

http://www.prostrakan.com

Funders

Funder type

Industry

Funder name

ProStrakan Pharmaceuticals (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

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16445786

Publication citations

  1. Results

    Kellett N, West F, Finlay AY, Conjoint analysis: a novel, rigorous tool for determining patient preferences for topical antibiotic treatment for acne. A randomised controlled trial., Br. J. Dermatol., 2006, 154, 3, 524-532, doi: 10.1111/j.1365-2133.2005.07047.x.

Additional files

Editorial Notes