Prospective randomised controlled study on imiquimod 5% cream as pre-treatment of Mohs micrographic surgery for primary large nodular basal cell carcinoma in the face.

Prospective randomised controlled study on imiquimod 5% cream as pre-treatment of Mohs micrographic surgery for primary large nodular basal cell carcinoma in the face. - Prospectief randomised study on imiquimod as pre-treatment of MMS

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31041

Enrollment

Registered

2007-07-30

Start date

2007-05-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

basal cell carcinoma skin cancer

Interventions

Product: Imiquimod 5% cream (Aldara®) applied locally on the skin, on the target tumour and 1 cm around the tumour. The cream has to be applied at night and left for approximately 8 hours. It has to

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients > 18 yrs Nodular/ nodular and partially superficial basal cell carcinoma in the face Diameter 1-5 cm

Exclusion criteria

Exclusion criteria: pregnant women women who breastfeed Recurrent BCC BCC with agressive growth pattern BCC within 1 cm from the eyes, lips or mucosa of the nose Another skin cancer within 5 cm of the target tumor Former treatment of BCC in the target area Allergy for imiquimod cream or substances

Design outcomes

Primary

Measure	Time frame
Defect sizes: Sizes are measured (in mm2), between group differences are calculated.	—

Secondary

Measure	Time frame
Tumour sizes: Sizes are measured, between group differences are calculated (imiquimod versus control group). In addition sizes pre and post imiquimod treatment (in the imiquimod group) will be compared. Increase in area from baseline lesion to post-MMS defects are calculated and compared between both groups. Reconstruction time will be measered in both groups and the between group difference will be noted. Cost analysis: Between group differences for total costs will be compared. These costs will be related to decrease in defect size and cosmetic result. Cosmetic outcome: Outcomes of the visual analog scale will be compared for both groups. Quality of life: A questionnaire will be used to compare both treatments. Before treatment, 4 weeks and 3 months after treatment.	—

Measure

Time frame

Tumour sizes: Sizes are measured, between group differences are calculated (imiquimod versus control group). In addition sizes pre and post imiquimod treatment (in the imiquimod group) will be compared. Increase in area from baseline lesion to post-MMS defects are calculated and compared between both groups. Reconstruction time will be measered in both groups and the between group difference will be noted. Cost analysis: Between group differences for total costs will be compared. These costs will be related to decrease in defect size and cosmetic result. Cosmetic outcome: Outcomes of the visual analog scale will be compared for both groups. Quality of life: A questionnaire will be used to compare both treatments. Before treatment, 4 weeks and 3 months after treatment.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)