MREC Reviewer Comment
Protocol Title
Fractional CO2 laser with topical insulin application for the treatment of striae alba
Completely satisfied and informative data
Needs Explanation
Comments to the applicant
Regarding Informed Consent:
- It must be revisited to remove irrelevant sections or paragraphs as well as complete any missed information.
- Emphasize more about the study procedures and the possible side effects.
Regarding Protocol:
- Modify age to 21 and above
- How the sample size calculated (formula and references)
- No reference for using insulin topically for striae alba as well as the dosage (5 IU) and the provided clinical assessment
- Which Insulin (Brand) & Why ?
- Quantitative outcome(s) should be considered from clinical, laboratory and statistical perspectives
Comment to the Committee
Informed consent form:
Needs Modification
