INTRODUCTION
Isotretinoin (13-cis-retinoic acid) is widely used for severe acne; however, due to its teratogenicity, it is strictly regulated.1 iPLEDGE was implemented in 2005 to minimize the potential fetal exposure to isotretinoin.1 The FDA announced in October 2021 that changes to the iPLEDGE system (including gender neutral options for patient risk categories and changes to the current pharmacy management system) would take effect on December 13, 2021.2 While the new changes were welcomed by dermatologists, they were accompanied by a change in vendors and the creation of a new platform, leading to a frustrating and stressful situation for both providers and patients due to issues with accessing the iPLEDGE portal.3 Many providers were left unable to prescribe isotretinoin to their patients, leading to a widespread disruption in patient care.3 A potential substitute for isotretinoin could prove beneficial when the drug is unavailable or unaffordable.
Prior to the FDA approval of isotretinoin, vitamin A was widely researched for use in chemoprevention and acne treatment. The first report of vitamin A being successful in treating acne was published in 1943.4 Following these results, the use of vitamin A for acne underwent clinical trials until isotretinoin was approved in 1982. We examined the published literature on the use of vitamin A from 1934-2021 using the databases PubMed and Google Scholar to assess its ability to serve as an alternative to isotretinoin for patients with acne. Nine studies (8 clinical trials and one case study) were included after evaluation for relevancy to the topic of interest.
Of the 9 trials reviewed, 8 had improvement in patients’ acne using vitamin A (Table 1). Treatment doses ranged from 36,000 IU daily to 500,000 IU daily.4-12 Forty-four percent of trials used 100,000 IU daily with success. Treatment lengths ranged from 1 month to 7 months. Mean duration until clinical improvement ranged from 7 weeks to 4 months after initiation of therapy. Relapse was noted in 33% of the trials included, however, this is comparable to the relapse rates (13-42%) noted for isotretinoin. In the clinical trials reviewed for both vitamin A and isotretinoin, the most frequent side effects were mucocutaneous, such as cheilitis and xerosis. At doses of 500,000 IU daily, mucocutaneous side effects were more severe, however, no serious side effects were noted. Benign elevations
Prior to the FDA approval of isotretinoin, vitamin A was widely researched for use in chemoprevention and acne treatment. The first report of vitamin A being successful in treating acne was published in 1943.4 Following these results, the use of vitamin A for acne underwent clinical trials until isotretinoin was approved in 1982. We examined the published literature on the use of vitamin A from 1934-2021 using the databases PubMed and Google Scholar to assess its ability to serve as an alternative to isotretinoin for patients with acne. Nine studies (8 clinical trials and one case study) were included after evaluation for relevancy to the topic of interest.
Of the 9 trials reviewed, 8 had improvement in patients’ acne using vitamin A (Table 1). Treatment doses ranged from 36,000 IU daily to 500,000 IU daily.4-12 Forty-four percent of trials used 100,000 IU daily with success. Treatment lengths ranged from 1 month to 7 months. Mean duration until clinical improvement ranged from 7 weeks to 4 months after initiation of therapy. Relapse was noted in 33% of the trials included, however, this is comparable to the relapse rates (13-42%) noted for isotretinoin. In the clinical trials reviewed for both vitamin A and isotretinoin, the most frequent side effects were mucocutaneous, such as cheilitis and xerosis. At doses of 500,000 IU daily, mucocutaneous side effects were more severe, however, no serious side effects were noted. Benign elevations