Reviewer ’s report  
 
Title:  Therapeutic comparison between treatments for Vulvar Lichen Sclerosus: study protocol 
of a randomized prospective and controlled trial.  
 
Version: 0 Date: 20 Jan 2017 
 
Reviewer:  Matthias  Jentschke  
 
Reviewer’s report:  
 
The authors present the study protocol for an upco ming trail about PDT and PBM in lichen 
sclerosus patients.  
 
Several aspects should be explained in greater detail to justify preliminary publication of the 
study protocol before the beginning of the trail as most information could also be included in the 
final publication after the trail is finished.  
 
Please explain how you defined the sample sizes. Did you perform some kind of power analysis? 
What are the expected differences in the success rate of the different treatment modalitites?  
 
Please explain in great er detail the treatment process. How much of the photosensitizer has to be 
applied at which time before treatment? Do the patients apply the photosensitizer by themselves 
at home and come to the clinic later? Are they allowed to walk around with the photos ensitizer 
or do they have to lay still?  
 
How is the light applied? What light source is used?  
 
Under 2.3 you refer to a pilot study that you did before however there is no reference and no 
further information about this pilot study. Please give the correct r eference or give more 
information about this pilot study.  
 
You are planning the final examination of the patients 30 days after the beginning of the 
treatment which will last 4 weeks. I think it would be good to include a final clinical examination 
of all p articipants after 2 or 3 months to evaluate the long -term response.  
 
Are the methods appropriate and well described?  
If not, please specify what is required in your comments to the authors.  
 
No 
 
Does the work include the necessary controls?  
If not, please specify  which controls are required in your comments to the authors.  
 
Yes 
 
Are the conclusions drawn adequately supported by the data shown?  
If not, please explain in your comments to the authors.  
 
Unable to assess  
 
Are you able to assess any statistics in the manuscript or would you recommend an 
additional statistical review?  
If an additional statistical review is recommended, please specify what aspects require further 
assessment in your comments to the editors.  
 
Not relevant to this manuscript  
 
Quality of written English  
Please indicate the quality of language in the manuscript:  
 
Acceptable  
 
Declaration of competing interests  
Please complete a declaration of competing interests, considering the following questions:  
 
1. Have you in the past five years received reimbursements, fees, funding, or salary from an 
organisation that may in any way gain or lose financially from the publication of this 
manuscript, either now or in the future?  
 
2. Do you hold any stocks or shares in an organisati on that may in any way gain or lose 
financially from the publication of this manuscript, either now or in the future?  
 
3. Do you hold or are you currently applying for any patents relating to the content of the 
manuscript?  
 
4. Have you received reimbursements, f ees, funding, or salary from an organization that 
holds or has applied for patents relating to the content of the manuscript?  
 
5. Do you have any other financial competing interests?  
 
6. Do you have any non -financial competing interests in relation to this paper ? 
 
If you can answer no to all of the above, write 'I declare that I have no competing interests' 
below. If your reply is yes to any, please give details below.  
 
I declare that I have no competing interests  
 
I agree to the open peer review policy of the journal. I understand that my name will be  included 
on my report to the authors and, if the manuscript is accepted for publication, my named report 
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which I do not wish to be included in my named report can be included as confidential comments 
to the editors, which will not be published.  
 
I agree to the open peer review policy of the journal