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
Secondary identifying numbers ZCG/4/C
Submission date
09/09/2005
Registration date
06/10/2005
Last edited
17/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof WJ Cunliffe
Scientific

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

Study information

Study designMulticentre randomised active controlled parallel group trial
Primary study designInterventional
Secondary study designMulti-centre
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesTo 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) studiedMild to moderate acne vulgaris.
InterventionZindaclin® 1% Gel (twice a day [bd] & once a day [od]) and Dalacin-T® Topical Lotion (bd).
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Zindaclin® 1% Gel and Dalacin-T® Topical Lotion
Primary outcome measureThe change in facial inflammatory lesion count from baseline visit to the end of treatment (week 16).
Secondary outcome measures1. 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
Overall study start date19/07/1999
Completion date29/09/2000

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants270
Key inclusion criteriaConsenting 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 criteria1. 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 enrolment19/07/1999
Date of final enrolment29/09/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Dermatology
Leeds
LS1 3EX
United Kingdom

Sponsor information

ProStrakan Pharmaceuticals (UK)
Industry

Buckholm Mill Brae
Galashiels
TD1 2HB
United Kingdom

ROR logo "ROR" https://ror.org/017hh7b56

Funders

Funder type

Industry

ProStrakan Pharmaceuticals (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2005 Yes No