Regulatory Decision Summary for Retin-A

Retin-A (tretinoin) is currently marketed in Canada as gel and cream formulations for treatment of acne vulgaris in adults only. The sponsor proposed herein the first lotion formulation for Retin-A (tretinoin) and an expansion of the target population to include pediatric patients 9 years of age and above.

Retin-A Lotion was shown to be superior to its vehicle lotion in reducing the number of inflammatory and comedonal facial acne lesions and achieving treatment success. The product was well tolerated by most of the study subjects. The only adverse drug reactions noted were application site reactions and skin-related events as would be expected for topically applied acne products. Some uncertainty remains in regards to the persistence of efficacy beyond 12 weeks, which was the maximum treatment duration in the pivotal clinical studies. However, considering the insignificant proportion of patients who discontinued the study due to lack of efficacy and the improved treatment outcomes over the course of each of the studies, there was reportedly no evidence of tolerance effect. Patient demographic factors, such as age, sex, ethnicity, race, and geographic location, as well as disease severity had no influence on the treatment effect relative to the outcome of interest.

Following the review of the safety, efficacy, and quality data provided by the sponsor, the revised Retin-A Product Monograph dated December 22, 2020 (sequence 0023) is considered acceptable. The risks identified with the use of this drug have been appropriately mitigated, including those for special populations such as pregnant and breastfeeding women and those with fish allergies. The Patient Medication Information (PMI) section and corresponding Package Insert were also updated to reflect the approved changes from the Part I of the Product Monograph. The overall benefit-harm-uncertainty profile of Retin-A Lotion is considered to be favourable when the drug is administered to patients under the conditions specified in the labeling.