Treatment of large nodular facial BCC with imiquimod 5% cream before Mohs micrographic surgery.

Prospective Randomised study on imiquimod 5% cream as pretreatment of Mohs micrographic surgery for primary large nodular basal cell carcinoma in the face to reduce the post-Mohs defect size.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23593

Enrollment

Registered

2007-10-04

Start date

2007-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Basal cell carcinoma

Interventions

40 patients receive Mohs micrographic surgery with a pretreatment with imiquimod (once daily, 5 days a week, 4 weeks) 40 patients will only undergo Mohs surgery.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients > 18 years; 2. Primary BCC, nodular or nodular and partially superficial; 3. BCC in the face; 4. BCC size 1-5 cm in diameter.

Exclusion criteria

Exclusion criteria: 1. Pregnant women; 2. Women who breastfeed; 3. Recurrent BCC; 4. Agressive growth pattern (squamous, morpheaform, infiltrative); 5. BCC within 1 cm from the eyes, lips or mucosa of the nose; 6. Another skin cancer within 5cm of the target tumour; 7. Former treatment of BCC in the target area; 8. Allergy for imiquimod 5% cream or substances of the cream.

Design outcomes

Primary

Measure	Time frame
Defect size after Mohs micrographic surgery.	—

Secondary

Measure	Time frame
1. Reduction tumour size after using imiquimod 5%cream; 2. Tumour size before Mohs micrographic surgery; 3. Reconstruction time; 4. Cosmetic outcome; 5. Costs; 6. Quality of Life; 7. Recurrence rates; 8. Histologic results, apoptosis.	—

Contacts

Public ContactS Geer van der

Catharina Hospital Eindhoven, department of dermatology Michelangelolaan 2

simone.vd.geer@cze.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)