Polidocanol Topical for Varicose Veins Treatment
Polidocanol injectable foam (Varithena) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee, but is not recommended as a topical agent for varicose veins. 1
FDA-Approved Indications and Administration
- Polidocanol injectable foam (Varithena) is specifically FDA-approved for intravenous use to treat incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the GSV system 1
- The administration should be performed under ultrasound guidance when treating the GSV, using up to 5 mL per injection and 15 mL per treatment session 1
- Treatment sessions should be separated by a minimum of 5 days 1
Treatment Algorithm for Varicose Veins
- First-line treatment for symptomatic varicose veins with documented valvular reflux is endovenous thermal ablation (radiofrequency or laser) 2, 3
- Second-line treatment is sclerotherapy, particularly for small to medium-sized veins (1-5 mm) 2, 3
- Third-line treatment is surgery, according to clinical guidelines 3
Mechanism and Efficacy of Polidocanol
- Polidocanol works as a sclerosing agent by causing inflammation of the vascular endothelium, resulting in fibrosis and occlusion of the vein 3
- When used as injectable foam, polidocanol has demonstrated occlusion rates of 72-89% at 1 year for treating varicose veins 2, 4
- Foam sclerotherapy has shown superior efficacy compared to liquid sclerotherapy, with 84% elimination of reflux in the GSV with foam versus 40% with liquid sclerosant 4
Patient Selection Criteria
- For sclerotherapy to be considered medically necessary, veins must be ≥2.5mm in diameter measured by ultrasound 2, 5
- Documented reflux duration ≥500 milliseconds in the veins to be treated is required 2, 5
- Patients should have failed a 3-month trial of conservative management, including compression therapy 2, 5
Safety Considerations
- Common adverse events include pain/discomfort in extremity, infusion site thrombosis, injection site hematoma or pain, thrombophlebitis superficial, and extravasation 1
- Rare but serious adverse events include anaphylaxis, tissue ischemia and necrosis (if injected intra-arterially), and venous thrombosis 1
- Polidocanol should not be used in patients with known allergy to the agent or acute thromboembolic disease 1
Off-Label Uses of Polidocanol
- While polidocanol has numerous off-label dermatological applications, it is not FDA-approved or recommended as a topical agent for varicose veins 6, 7
- Topical application of polidocanol-containing lotions has been mentioned only for symptomatic relief of pruritus/itching associated with skin conditions, not as a primary treatment for varicose veins 8
Important Clinical Considerations
- Ultrasound guidance is essential for the safe and effective performance of sclerotherapy procedures 2
- Treating the saphenofemoral and saphenopopliteal junctions is critical for long-term success, as studies show that chemical sclerotherapy alone has worse outcomes at 1-, 5-, and 8-year follow-ups compared to thermal ablation 2
- Vessels less than 2.0 mm in diameter treated with sclerotherapy had only 16% primary patency at 3 months compared with 76% for veins greater than 2.0 mm 2
Conclusion
- Polidocanol is not recommended as a topical agent for treating varicose veins 1
- For varicose vein treatment, polidocanol should be used as an injectable foam administered intravenously under ultrasound guidance 1
- The treatment approach should follow the established algorithm: endovenous thermal ablation first, sclerotherapy second, and surgery third 2, 3