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ISRCTN
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ISRCTN43187439
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ClinicalTrials.gov identifier
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Public title
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A randomised, single centre, phase IV crossover study to assess the acceptability of once daily Zindaclin® used for one week compared to three other marketed topical antibiotics in patients with mild to moderate acne
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Scientific title
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Acronym
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N/A
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Serial number at source
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ZCG/38/C
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Study hypothesis
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To assess the patient acceptability of Zindaclin® when compared to other marketed topical antibiotics.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised active controlled crossover group trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mild to moderate acne vulgaris.
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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20/02/2002
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Anticipated end date
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09/10/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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65
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Interventions
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1. Zindaclin® once daily
2. Benzamycin® twice daily
3. Zineryt® twice daily
4. Dalacin-T® Topical Lotion twice daily
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Primary outcome measure(s)
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Patient Acceptability Questionnaire assessing the four study products.
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Secondary outcome measure(s)
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1. A conjoint analysis assessment of product preferences
2. The level of product use
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Sources of funding
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ProStrakan Pharmaceuticals (UK)
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Trial website
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Publications
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Contact name
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Dr
Norma
Kellett
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Address
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Inveresk Research International
Elphinstone Research Centre
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City/town
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Tranent
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Zip/Postcode
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EH33 2NE
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Country
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United Kingdom
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Sponsor
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ProStrakan Pharmaceuticals (UK)
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Address
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Buckholm Mill Brae
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City/town
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Galashiels
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Zip/Postcode
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TD1 2HB
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Country
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United Kingdom
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Sponsor website:
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http://www.prostrakan.com
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Date applied
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09/09/2005
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Last edited
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17/09/2009
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Date ISRCTN assigned
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06/10/2005
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