Condition category
Skin and Connective Tissue Diseases
Date applied
09/09/2005
Date assigned
06/10/2005
Last edited
17/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof WJ Cunliffe

ORCID ID

Contact details

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

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 measures

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. Patient’s global assessment
5. Investigator’s global assessment

Overall trial start date

19/07/1999

Overall trial end date

29/09/2000

Reason abandoned

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

Sponsor information

Organisation

ProStrakan Pharmaceuticals (UK)

Sponsor details

Buckholm Mill Brae
Galashiels
TD1 2HB
United Kingdom

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16302325

Publication citations

  1. 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.

Additional files

Editorial Notes