Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZCG/4/C
Study information
Scientific title
Acronym
Study hypothesis
To ascertain the efficacy of a new formulation of topical clindamycin gel.
Ethics approval
Not provided at time of registration
Study design
Multicentre randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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 names
Zindaclin® 1% Gel and Dalacin-T® Topical Lotion
Primary outcome measure
The change in facial inflammatory lesion count from baseline visit to the end of treatment (week 16).
Secondary outcome measures
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
Overall trial start date
19/07/1999
Overall trial end date
29/09/2000
Reason abandoned (if study stopped)
Eligibility
Participant 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).
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
270
Participant 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
Recruitment start date
19/07/1999
Recruitment end date
29/09/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Dermatology
Leeds
LS1 3EX
United Kingdom
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
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16302325
Publication citations
-
Results
Cunliffe WJ, Fernandez C, Bojar R, Kanis R, West F, , An observer-blind parallel-group, randomized, multicentre clinical and microbiological study of a topical clindamycin/zinc gel and a topical clindamycin lotion in patients with mild/moderate acne., J Dermatolog Treat, 2005, 16, 4, 213-218.