What is the recommended treatment regimen for molluscum contagiosum using Aldara (imiquimod)?

Molluscum Contagiosum Treatment: Imiquimod Not Recommended

Imiquimod is not recommended for the treatment of molluscum contagiosum as randomized controlled trials have shown it is not more effective than placebo. 1 Instead, other treatment options should be considered for patients with bothersome or extensive lesions.

Evidence Against Imiquimod for Molluscum Contagiosum

The FDA drug label specifically states that imiquimod cream has been evaluated in children with molluscum contagiosum and these studies failed to demonstrate efficacy 2. Two randomized, vehicle-controlled, double-blind trials involving 702 pediatric subjects with molluscum contagiosum showed:

• Study 1: Complete clearance rate of 24% in the imiquimod group vs. 26% in the vehicle (placebo) group
• Study 2: Clearance rates of 24% in the imiquimod group vs. 28% in the vehicle group 2

These findings clearly demonstrate that imiquimod is not superior to placebo for treating molluscum contagiosum.

Recommended First-Line Treatments

For patients requiring treatment, the following options are recommended:

1. Cryotherapy with liquid nitrogen: Applied every 1-2 weeks until lesions resolve, with a high efficacy rate of 93.3% complete response 1

2. Cantharidin application: Well-tolerated and effective for children and adults 1

3. 10% Potassium hydroxide (KOH): Comparable efficacy to cryotherapy with an 86.6% complete response rate 1

Treatment Algorithm for Molluscum Contagiosum

1. For limited, asymptomatic lesions in immunocompetent patients:

   • Consider observation for spontaneous resolution with monitoring for 3-6 months 1

2. For bothersome, extensive, or symptomatic lesions:

   • First-line: Cryotherapy, cantharidin, or 10% KOH 1
   • Second-line: Surgical options (curettage, excision) for immediate removal of lesions 1

3. For lesions near eyes:

   • Prompt treatment is recommended to prevent conjunctivitis 1

4. For multiple lesions:

   • Identify and treat nascent lesions to reduce recurrence risk 1
   • Regular monitoring every 1-3 months to assess progression 1

Prevention of Spread

• Cover visible lesions with clothing or bandages when possible
• Maintain good hand hygiene, especially after touching lesions
• Avoid sharing personal items like towels and clothing
• Avoid scratching or picking at lesions to prevent autoinoculation 1

Important Considerations

While some older, smaller studies suggested potential benefit of imiquimod for molluscum 3, 4, these findings have been contradicted by larger, more recent randomized controlled trials that found no benefit over placebo 1, 2.

Additionally, imiquimod can cause significant local skin reactions including erythema (28%), edema (8%), scabbing/crusting (5%), flaking/scaling (5%), erosion (2%), and weeping/exudate (2%) 2. These side effects must be considered, especially in children who may not tolerate the treatment well.

For these reasons, other treatment options with demonstrated efficacy should be prioritized over imiquimod for the management of molluscum contagiosum.