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

ISRCTN	ISRCTN43187439
DOI	https://doi.org/10.1186/ISRCTN43187439
Protocol serial number	ZCG/38/C
Sponsor	ProStrakan Pharmaceuticals (UK)
Funder	ProStrakan Pharmaceuticals (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Norma Kellett
Scientific

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

Primary study design	Interventional
Study design	Randomised active controlled crossover group trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To assess the patient acceptability of Zindaclin® when compared to other marketed topical antibiotics.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Zindaclin®, Benzamycin®, Zineryt®, Dalacin-T®
Primary outcome measure(s)	Patient Acceptability Questionnaire assessing the four study products.
Key secondary outcome measure(s)	1. A conjoint analysis assessment of product preferences 2. The level of product use
Completion date	09/10/2002

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	65
Key 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.
Key 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
Date of first enrolment	20/02/2002
Date of final enrolment	09/10/2002

Inveresk Research International

Tranent
EH33 2NE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2006		Yes	No