From the Guidelines
Actikerall (5-fluorouracil and salicylic acid) is not recommended for use in children with warts due to its potential for significant skin irritation and lack of established safety and efficacy in pediatric populations. According to the British Association of Dermatologists' guidelines for the management of cutaneous warts 2014 1, safer alternatives for children include salicylic acid preparations and cryotherapy. The guidelines suggest that warts in children are often relatively short-lived and may clear within a year or two, making watchful waiting a viable option. For hand and foot warts in children, the recommended treatments include salicylic acid (15–40%) topical paints or ointments and cryotherapy, gentle, fortnightly for 3–4 months 1.
The use of 5-fluorouracil, a component of Actikerall, is mentioned in the guidelines as a possible treatment for hand warts, but with a lower strength of recommendation and without specific guidance for pediatric use 1. Given the potential risks and the availability of safer alternatives, it is prudent to avoid using Actikerall in children. Instead, consultation with a pediatrician or dermatologist is advised to determine the most appropriate treatment approach for a child's warts, considering factors such as the location, size, and number of warts, as well as the child's overall health and tolerance for potential treatments.
Key considerations in managing warts in children include:
- Avoiding painful treatments whenever possible
- Using treatments with established safety and efficacy in pediatric populations
- Monitoring for potential side effects and adjusting treatment as needed
- Considering the benign nature of most warts and the potential for spontaneous resolution.
From the FDA Drug Label
Salicylic Acid 6% should not be used in children under 2 years of age. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity Due to potential risk of developing Reye's syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by physician.
The use of Actikerall (5-fluorouracil and salicylic acid) in children for warts is not explicitly addressed in the provided drug labels. However, based on the information available for salicylic acid, caution is advised.
- Children under 2 years: Salicylic acid should not be used.
- Children under 12 years: The area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity 2, 2. It is essential to consult a physician before using Actikerall in children, especially considering the potential risks associated with salicylic acid.
From the Research
Actikerall Use in Children for Warts
- Actikerall, a combination of 5-fluorouracil and salicylic acid, is used to treat warts in children.
- According to a study published in 2009 3, topical 5% 5-fluorouracil is a safe, effective, and well-tolerated treatment for warts in children, with 88% of treated warts improving after 6 weeks of treatment.
- The study found that 41% of subjects had complete resolution of at least one wart, and 87% of complete responders had no wart recurrence at 6-month follow-up.
- Another study published in 2011 4 provides an update on research in the field of viral cutaneous wart therapies, including safety issues and potential complications of therapy in pediatric patients.
- However, this study does not specifically address the use of Actikerall in children.
- Other studies have investigated alternative treatments for warts in children, including squaric acid therapy 5, pulsed dye laser therapy 6, and monochloroacetic acid application 7.
- These studies suggest that there are various effective and safe treatment options available for warts in children, but the use of Actikerall specifically is only supported by the 2009 study 3.
Safety and Efficacy
- The safety and efficacy of Actikerall in children have been demonstrated in the 2009 study 3, which found that topical 5% 5-fluorouracil is well-tolerated and effective in treating warts in children.
- The study reported no clinically significant blood levels of 5-fluorouracil and excellent patient satisfaction.
- However, more research is needed to confirm the long-term safety and efficacy of Actikerall in children.
Comparison with Other Treatments
- The effectiveness of Actikerall in children can be compared to other treatments, such as squaric acid therapy 5 and pulsed dye laser therapy 6.
- These studies suggest that there are various effective treatment options available for warts in children, and the choice of treatment may depend on individual patient needs and preferences.