Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT01358045|
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : January 13, 2015
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma||Drug: Diclofenac Drug: Diclofenac + Calcitriol Drug: Calcitriol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||May 2013|
|Active Comparator: Solaraze||
Application on the lesion 2 times a day 8 weeks.
Other Name: Solaraze
|Active Comparator: Solaraze + Silkis||
Drug: Diclofenac + Calcitriol
Application on the lesion 2 times a day, both ointments, 8 weeks.
Other Name: Solaraze + Silkis
|Active Comparator: Silkis||
Application on the lesion, 2 times a day, 8 weeks.
Other Name: Silkis
|No Intervention: No treatment|
- Histological changes in different proliferation and apoptosis markers. [ Time Frame: At baseline and after 8 weeks. ]To determine the change in mean percentage of cells expressing Ki67 and BCL2 after topical application of Calcitriol (Silkis) 3 μg/g, Diclofenac 3% or a combination of both.
- Macroscopic tumour changes [ Time Frame: Baseline and after 8 weeks. ]We want the observe if the tumour will also macroscopically change within 8 weeks of treatment. Things were we will focus on will be size and colour.
- Toleration [ Time Frame: 8 weeks ]We want to evaluate if the patients will tolerate the therapy. Main points in here will be irritation of the skin and the amount of time this therapy costs the patients.
- Compliance [ Time Frame: 8 weeks ]Data for compliance with the prescribed regimens of either diclofenac sodium-3% gel, calcitriol 3µg/g ointment or a combination of both will be obtained from a personal diary kept by patients and completed once a week during treatment. Compliance was calculated as the number of applications done by the patient divided by the total prescribed number of applications.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358045
|Maastricht University Medical Center|
|Maastricht, Limburg, Netherlands, 6202 AZ|