1- Subject area is stated as animal studies, while the study is human subject research
2- Hypothesis is not stated
3- What are JAK inhibitors? Please write in full for the first time mentioned in the protocol
4- Background is too short.
a- What is ruxolitinib?
b- What are the side effects of ruxolitinib?
c- What are the side effects of CO2 laser?
5- Procedures:
a-CO2 fractional laser, how will it be applied, where and by whom?
b- How will re-pigmentation be measured objectively?
6- How was the sample size calculated from the reference, and please provide the reference.
7- The chart provided is not a chart, please provide a chart
8- The protocol uses laser, but the question "Does this protocol involve the use of substances..." is answered as "No". Please write the laser use precautions in the protocol.
9- Age range is starting at 15 years.
a-These are children. Please justify involving children in the research and the measurements of their protection.
b-Children are also considered a vulnerable population and the question for vulnerable population is answered as "no".
10- Risks and side effects cannot be "none".
e.g. the monthly visits are a risk (financial and time)
What side effects are mentioned in the literature of the cream and for the laser? etc.
11- "Twice daily for 6 months" This is not a benefit for participants, even if the investigator is providing the cream.
12- "Limiting access to information" how will the access by limits?
13- "The research will have a direct or potential benefit, in the present or future, for the population
yes"
What are the potential direct benefits to both groups, that are not available to other patients who did not participate in the study?z
14- No consent and assent were provided for review