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
Scientific
Department of Dermatology
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
Study information
Study design | Multicentre randomised active controlled parallel group trial |
---|---|
Primary study design | Interventional |
Secondary study design | Multi-centre |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 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 study start date | 19/07/1999 |
Completion date | 29/09/2000 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Other |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Dermatology
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
ProStrakan Pharmaceuticals (UK)
Industry
Industry
Buckholm Mill Brae
Galashiels
TD1 2HB
United Kingdom
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |