From the FDA Drug Label
Apply Tolak Cream once daily in an amount sufficient to cover the lesions of the face, ears, and/or scalp with a thin film, using the fingertips to gently massage the medication uniformly into the skin (2). Tolak Cream should be applied for a period of 4 weeks as tolerated (2). The correct application frequency for Tolak (fluorouracil) Cream, 4%, is once daily for 4 weeks for Actinic Keratosis (AK) management 1.
From the Research
For management of actinic keratosis (AK), Tolak 4% cream (diclofenac 4%) should be applied once daily for 4 weeks, as this regimen has been shown to be effective and well-tolerated in clinical trials 2. The choice of application frequency is crucial in balancing efficacy and tolerability. According to the most recent and highest quality study, applying Tolak 4% cream once daily for 4 weeks is the recommended regimen 2. This study demonstrated a significant decrease in Actinic Keratosis Area and Severity Index (AKASI) score at both 6 and 12 weeks, with minimal adverse reactions and no unexpected adverse events.
Key points to consider when using Tolak 4% cream for AK management include:
- Applying a thin layer to the affected areas once daily
- Thoroughly washing hands after application
- Expecting local skin reactions such as redness, irritation, burning, and inflammation, which are normal signs that the medication is working
- Avoiding sun exposure during treatment as the skin will be more sensitive to UV radiation
- Considering a second course of treatment if lesions persist after one treatment cycle, after allowing the skin to fully recover
It is essential to note that the provided evidence does not support the use of Tolak 4% cream (diclofenac 4%) twice daily for 4 weeks, as the most recent and highest quality study recommends once daily application 2. Additionally, the evidence suggests that diclofenac 3% gel is a different formulation and should not be confused with Tolak 4% cream (diclofenac 4%) 3.
In terms of efficacy and safety, the once daily application of Tolak 4% cream for 4 weeks has been shown to be effective in reducing AK lesions and is well-tolerated, with minimal adverse reactions 2. This regimen is also supported by expert opinion, which highlights the importance of treatment choice based on patient-, lesion-, and treatment-related considerations 4.