What is Actikerall and How Does it Work?
Actikerall is a unique, two-component cutaneous solution designed for targeted dermatological treatment. It combines two active substances: 5-fluorouracil (FU) and salicylic acid (SA). This combination allows the medication to work effectively against hyperkeratotic (thickened) skin lesions.
- 5-Fluorouracil (FU): As a cytostatic agent, fluorouracil functions as an antimetabolite, preventing the formation and use of thymine, a crucial component for nucleic acid synthesis in rapidly dividing cells. This inhibits the growth of the abnormal skin cells found in actinic keratosis.
- Salicylic Acid (SA): This component is a keratolytic, meaning it softens and dissolves hard, scaly skin. By breaking down the thickened outer layer of the actinic keratosis lesion, salicylic acid significantly improves the penetration of the fluorouracil into the abnormal cells, enhancing its therapeutic effect.
The combined action of these two ingredients makes Actikerall a highly effective option for addressing the specific needs of hyperkeratotic actinic keratosis lesions.
Primary Medical Use: Actinic Keratosis
The primary and approved use for Actikerall cutaneous solution is the topical treatment of mild to moderate, hyperkeratotic actinic keratosis (AK), also known as solar keratosis. Actinic keratoses are rough, scaly, or crusty patches of skin that develop on sun-exposed areas, such as the face, forehead, balding scalp, chest, and back of the hands. These lesions, while not cancerous themselves, are considered precancerous and carry a risk of progressing to squamous cell carcinoma.
Actikerall is typically prescribed for immunocompetent adult patients with these specific types of lesions on the face, forehead, and balding scalp. It can be used for individual lesions or as a "field treatment" to address a limited area with multiple lesions, up to a maximum of 25 cm² (5 cm x 5 cm) at a time.
Important Safety Precautions for Use
- Sunlight Sensitivity: The treated area of skin becomes more sensitive to sunlight and UV radiation. It is crucial to limit sun exposure, use protective clothing (like hats), and apply a high-SPF sunscreen daily, even after the treatment concludes.
- Flammability: The solution contains alcohol and is flammable. It should be kept away from open flames, lit cigarettes, and heat sources.
- Preventing Stains: Actikerall can permanently stain clothing, fabrics, or acrylic surfaces like bathtubs. Patients should be careful during application to avoid contact with these items.
- No Contact with Mucous Membranes: Avoid applying the solution to the eyes, inside the nose or mouth, or on the genitals. If accidental contact occurs, rinse the area with plenty of water.
- Not for Bleeding Lesions: The product should not be used on lesions that are bleeding.
Proper Application and Treatment Duration
For optimal results, it is essential to follow a strict application protocol. The solution is applied once daily using the provided brush applicator.
- Daily Application: Dab the solution onto each actinic keratosis lesion once a day. If treating a field of lesions, ensure the total area does not exceed 25 cm².
- Forming a Film: Allow the solution to dry and form a film over the treated area. Do not cover the area with a dressing.
- Film Removal: Before each subsequent application, the previous day's film coating should be gently peeled off. Warm water may assist with removal.
- Treatment Length: The treatment typically lasts until the lesions are completely cleared or for a maximum of 12 weeks. It is important to continue treatment for the full prescribed duration, even if improvement is not seen immediately, as clearance may continue for up to eight weeks after stopping treatment.
- Adjustments for Sensitive Skin: For thinner or more sensitive areas like around the eyes and temples, a doctor may advise less frequent application.
Comparison of Actikerall with Other AK Treatments
Treatment for actinic keratosis is often tailored to the specific type and location of the lesion. Actikerall offers a unique combination approach that contrasts with other common treatments.
Feature | Actikerall | Cryotherapy | Diclofenac Gel (Solaraze®) |
---|---|---|---|
Active Ingredients | 0.5% 5-Fluorouracil, 10% Salicylic Acid | Liquid Nitrogen | 3% Diclofenac Sodium |
Mechanism of Action | FU inhibits cell growth; SA softens thickened skin to aid penetration. | Freezes and destroys the lesion. | Reduces inflammation and inhibits cell proliferation. |
Application | Once daily topical solution applied by patient at home for up to 12 weeks. | In-office procedure, usually quick. | Twice daily topical gel applied by patient for 8-12 weeks. |
Tolerability | Predictable local skin reactions (burning, redness, peeling) are common. | Can cause pain during and after the procedure. | Generally well-tolerated and milder than Actikerall. |
Efficacy for Hyperkeratotic Lesions | Highly effective due to the keratolytic effect of salicylic acid. | Effective, but can leave scarring or pigmentation changes. | Less effective for thickened, hyperkeratotic lesions compared to Actikerall. |
Best Suited For | Mild to moderate hyperkeratotic AKs on face/scalp. | Individual or isolated lesions. | Broader areas of field cancerization where a milder approach is needed. |
Conclusion
Actikerall cutaneous solution serves as a targeted and effective treatment for specific types of sun-damaged skin lesions known as actinic keratoses. By combining the cell-inhibiting action of 5-fluorouracil with the skin-softening properties of salicylic acid, the medication offers a potent therapeutic approach, particularly for lesions that are thickened or scaly. As with any prescription medication, it is essential to follow the application instructions carefully and adhere to the specified precautions, including protecting the skin from further UV exposure. Patients undergoing treatment should consult with their healthcare provider regularly to manage side effects and monitor progress. For more detailed information, consult the electronic medicines compendium product information.