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
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
-
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.