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** This trial has now been published in the British Journal of Dermatology. 159(5):1186-91, 2008 Nov..
** The details for this ongoing trial will be displayed for six months .

Trial Details:

1. Unique trial number

CSG Trial No. 47

2. Trial registration date

The date of registration will be the date on which the CSG accepts and posts your ongoing trial on www.nottingham.ac.uk/ongoingskintrials.
Date accepted: 12 Mar 2007

3. Secondary IDs

Are there any other identification numbers (ID) assigned to this trial?
For example an ID assigned by sponsors or other interested parties (there may be none). If there are please list them.

4. Funding source(s)

Name of the organisation(s) that provided funding for the study:-
Own account? Yes/No Yes No

If 'Yes' please state the organisation that pays your salary:-
Who is funding the study? Select 'YES' to the question 'Own account?' if the study was done in your own time and not funded by an external grant.

5. Primary sponsor

Who is the main research group doing the research e.g. University of Michigan?

6. Secondary sponsor(s)

Please list the secondary entities, if any, responsible for performing the research e.g. other university collaborators.

7. Responsible contact person

Public contact person for the trial, for patients interested in participating.

8. Research contact person

Person to contact for scientific inquiries about the trial (this may be the same person as 7. above).

9. Title of the study

Brief title chosen by the research group (can be omitted if the researchers wish).
Is this a re-submission to the CSG?
Yes No

10. Official scientific title of the study

This title must include the name of the intervention, the condition being studied, and the outcome (e.g. Healing rates of pyoderma gangrenosum with e.g. topical tacrolimus versus topical corticosteroids).

11. Research ethics review

Has the study at the time of registration received appropriate ethics committee approval, Yes/No?

Yes No
(It is assumed that all registered trials will be approved by an ethics board before commencing.)

12. Condition

The medical condition being studied (e.g. atopic eczema, lichen planus, bullous pemphigoid).

13. Intervention(s)

A description of the study and comparison/control intervention(s). Please be sure to describe all study arms.' (For a drug or other product registered for public sale anywhere in the world, this is the generic name; for an unregistered drug the generic name or company serial number is acceptable). The duration of the intervention(s) must be specified.

14. Key inclusion and exclusion criteria

Please list key patient characteristics that determine eligibility for (or exclusion from) participation in the study.

15. Study type

Is this study randomised (Yes/No)?

Yes No

If 'Yes' what type of randomised controlled trial are you doing?

Factorial design
Internally controlled (right/left comparison study)
Parallel group study
Cross-over study
No treatment
Other

If "Other" please specify:-

Is the randomisation code concealed from the person entering people into the study (Yes/No)?

Yes No

What type of control is being used?

Placebo Active Established Intervention No Intervention

Is the study blinded (masked) Yes/No?

Yes No

If 'Yes' who is blinded in the study?

Patient Physician Assessor Statistician

16. Planned trial start/finish dates (dd-mm-yyyy)

Start: End:

Estimated enrollment date of the first participant and end date if appropriate.

17. Target sample size

The total number of subjects the investigators plan to enroll before closing the trial.

18. Recruitment status?

Yes No

Link URL:

Is this information available (Yes/No) (If yes, link to information).

19. Primary outcome

The primary outcome that the study was designed to evaluate. Description should include the time at which the outcome is measured (e.g., participant's assessment of cosmetically acceptable hair growth at six months)

20. Key secondary outcomes

The secondary outcomes specified in the protocol. Description should include time of measurement (e.g., terminal hair regrowth at six months).

21. Protocol

Please indicate that all the information above has been taken from the protocol of this study: Yes No

If 'No' then please indicate the date and version of the protocol:

Date:

Version:

22. Copy of protocol

Please send a copy of the protocol to CSG either electronically to finola.delamere@nottingham.ac.uk or by post to: Cochrane Skin Group, Centre of Evidence Based Dermatology, King's Meadow Campus, Nottingham University, NG7 2NR United Kingdom.

23. Your Contact Details

E-mail:

Telephone:

Fax:

Address:

Country:
 
   
 

Cochrane Skin Group, Centre of Evidence Based Dermatology, King's Meadow Campus, Nottingham University, NG7 2NR United Kingdom.  Tel:+44 115 (84) 68635 Fax: +44 115 (84) 68618

 

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