A randomised, single centre, phase IV crossover study to assess the acceptability of once daily Zindaclin® used for one week compared to three other marketed topical antibiotics in patients with mild to moderate acne
| ISRCTN | ISRCTN43187439 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43187439 |
| Secondary identifying numbers | ZCG/38/C |
- Submission date
- 09/09/2005
- Registration date
- 06/10/2005
- Last edited
- 01/08/2012
- 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
Dr Norma Kellett
Scientific
Scientific
Inveresk Research International
Elphinstone Research Centre
Tranent
EH33 2NE
United Kingdom
Study information
| Study design | Randomised active controlled crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To assess the patient acceptability of Zindaclin® when compared to other marketed topical antibiotics. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Mild to moderate acne vulgaris. |
| Intervention | 1. Zindaclin® once daily 2. Benzamycin® twice daily 3. Zineryt® twice daily 4. Dalacin-T® Topical Lotion twice daily |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Zindaclin®, Benzamycin®, Zineryt®, Dalacin-T® |
| Primary outcome measure | Patient Acceptability Questionnaire assessing the four study products. |
| Secondary outcome measures | 1. A conjoint analysis assessment of product preferences 2. The level of product use |
| Overall study start date | 20/02/2002 |
| Completion date | 09/10/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 65 |
| Key inclusion criteria | Male and female patients aged between 16 and 40 years with mild to moderate acne graded between 1.0 and 7.0 on the Leeds Revised Acne Grading System, 1998. |
| Key exclusion criteria | 1. Patients with acne conglobata, acne fulminans, sandpaper acne, submarine comedonal acne or secondary acne were excluded 2. The use of topical or systemic antibiotics or topical antimicrobials within the previous week was disallowed |
| Date of first enrolment | 20/02/2002 |
| Date of final enrolment | 09/10/2002 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Inveresk Research International
Tranent
EH33 2NE
United Kingdom
EH33 2NE
United Kingdom
Sponsor information
ProStrakan Pharmaceuticals (UK)
Industry
Industry
Buckholm Mill Brae
Galashiels
TD1 2HB
United Kingdom
| Website | http://www.prostrakan.com |
|---|---|
"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 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 | 01/03/2006 | Yes | No |
