A randomized, open, controlled trial of tretinoin 0.05% cream vs. low-dose oral isotretinoin for the treatment of field cancerization

Abstract

A randomized, open, controlled trial of tretinoin 0.05% cream vs. low-dose oral isotretinoin for the treatment of field cancerization Abstract Background Sun exposure may lead to actinic keratoses (AKs), field cancerization, and skin cancer. Effective treatment of AKs and field cancerization is important. Oral and topical retinoids can be used for this purpose. To compare clinical, histological, and immunohistochemical effects of oral and topical retinoid for AKs and field cancerization on face and upper limbs of immunocompetent patients, as well as the impact on quality of life, safety, and tolerability.Methods This study compared 10 mg/day oral isotretinoin (ISO) to 0.05% tretinoin cream (TRE) every other night, associated with sunscreen (SPF 60). Patients of both genders, aged 50-75 years, underwent cryotherapy with liquid nitrogen for AKs at baseline and after 120 days when they were randomized into two groups, TRE (n = 31) and ISO (n = 30), for 6 months. Outcome measures were: number of AKs, histological (thickness of stratum corneum and epithelium) and immunohistochemical parameters (p53, Bcl-2 and Bax), dermatology life quality index (DLQI), and adverse events.Results Both treatments reduced the number of AKs (around 28%), the thickness of stratum corneum, and expression of p53 and Bax. By contrast, the epithelium thickness and Bcl-2 expression increased. There was no difference in the outcomes between TRE and ISO. Both treatments improved quality of life and were well tolerated with minimal side effects. Conclusions Retinoids are effective and safe for field cancerization. Classical treatments for field cancerization (imiquimod and ingenol mebutate) are used for a short period; retinoids may be a good choice to intercalate with them and can be used continuously.

Response to the correspondence: a randomized, open, controlled trial of tretinoin 0.05% cream vs. low‐dose oral isotretinoin for the treatment of field cancerization

“…We suggested that retinoids can be considered as maintenance therapy with the purpose of stabilizing the skin field of cancerization, after a destructive treatment (e.g., cryosurgery). 8 Despite four basal-cell carcinomas detected throughout the study (secondary endpoint), our conclusions do not allow recommendations regarding the specific chemoprevention of skin cancer. 8 We also followed 34 excluded patients who only used sunscreen after cryosurgery.…”

“…8 Despite four basal-cell carcinomas detected throughout the study (secondary endpoint), our conclusions do not allow recommendations regarding the specific chemoprevention of skin cancer. 8 We also followed 34 excluded patients who only used sunscreen after cryosurgery. They disclosed an inferior performance (À27%) to both retinoid groups (À40%) in AK count reduction, providing evidence that retinoids can benefit the treatment of field cancerization.…”

Low dose of isotretinoin: A comprehensive review

“…Retinoids have propable chemopreventive properties through its effect on mutations of p53 protein, together with normalization of epithelial cellular differentiation and deactivation of the apoptotic pathways. Researchers suggested isotretinoin in a dose of 10 mg/day can be a safe alternative for treatment of the precancerous actinic keratosis (Ianhez, Pinto, Bagatin, & Miot, ). Furthermore, maintenance therapy with retinoids, including low‐dose isotretinoin, is suggested for stabilization of the skin field of cancerization (Ianhez, Pinto, Miot, & Bagatin, ).…”

Response to: A randomized, open, controlled trial of tretinoin 0.05% cream vs. low‐dose oral isotretinoin for the treatment of field cancerization

“…Their data demonstrate no difference in the number of AKs at the end of the trial between the two groups . They conclude that both treatments were effective for field cancerization, a conclusion unrelated to the random assignment of treatments.…”

“…It is with interest that we read the paper by Ianhez et al . on retinoid use in patients with field cancerization . The authors are reporting a randomized clinical trial with 61 participants that compares the efficacy of 0.05% tretinoin cream vs. oral isotretinoin for the treatment of actinic keratoses (AKs).…”