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

ISRCTN	ISRCTN72179764
DOI	https://doi.org/10.1186/ISRCTN72179764
Protocol serial number	ZCG/4/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

Prof WJ Cunliffe
Scientific

Department of Dermatology
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Primary study design	Interventional
Study design	Multicentre randomised active controlled parallel group trial
Secondary study design	Multi-centre
Scientific title
Study objectives	To ascertain the efficacy of a new formulation of topical clindamycin gel.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mild to moderate acne vulgaris.
Intervention	Zindaclin® 1% Gel (twice a day [bd] & once a day [od]) and Dalacin-T® Topical Lotion (bd).
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Zindaclin® 1% Gel and Dalacin-T® Topical Lotion
Primary outcome measure(s)	The change in facial inflammatory lesion count from baseline visit to the end of treatment (week 16).
Key secondary outcome measure(s)	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. Patients global assessment 5. Investigators global assessment
Completion date	29/09/2000

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	270
Key inclusion criteria	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).
Key exclusion criteria	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
Date of first enrolment	19/07/1999
Date of final enrolment	29/09/2000

Department of Dermatology

Leeds
LS1 3EX
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	01/09/2005		Yes	No