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ISRCTN
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ISRCTN72179764
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ClinicalTrials.gov identifier
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Public title
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An observer blind, parallel group, randomised multicentre study to compare the safety and efficacy of a new formulation of topical clindamycin phosphate 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/4/C
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Study hypothesis
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To ascertain the efficacy of a new formulation of topical clindamycin gel.
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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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Multicentre randomised active controlled parallel 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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Consenting patients of either sex, between 12 and 40 years of age, with mild to moderate inflammatory acne with a grade ranging from 2.0 to 7.0 (The Leeds Revised Acne Grading System, 1998).
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Participants - exclusion criteria
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1. Patients with significant nodulocystic acne
2. Use of systemic topical antibiotics within 4 weeks prior to the start of treatment
3. Concomitant medication which may interfere with study evaluation
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Anticipated start date
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19/07/1999
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Anticipated end date
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29/09/2000
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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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270
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Interventions
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Zindaclin® 1% Gel (twice a day [bd] & once a day [od]) and Dalacin-T® Topical Lotion (bd).
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Primary outcome measure(s)
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The change in facial inflammatory lesion count from baseline visit to the end of treatment (week 16).
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Secondary outcome measure(s)
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1. The change in acne grade (The Leeds Revised Acne Grading System, 1998) from the baseline visit to the end of treatment
2. The change in number of total comedones, open comedones, closed comedomes, pustules
3. Mean change in total lesion count
4. Patient’s global assessment
5. Investigator’s global assessment
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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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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16302325
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Contact name
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Prof
WJ
Cunliffe
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Address
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Department of Dermatology
Leeds General Infirmary
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City/town
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Leeds
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Zip/Postcode
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LS1 3EX
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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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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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