Ignite Creation Date:
2024-05-05 @ 11:32 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01358045
Status:
COMPLETED
Last Update Posted:
2015-01-13
First Post:
2011-05-17
Brief Title:
Topical Vitamin D3 Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
Topical Vitamin D3 Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Basal cell carcinoma BCC is the most frequent malignant tumor in Caucasians and the incidence is still increasing with 3-8 each year Since BCCs generally occur on sun-exposed areas of the skin the rice in incidence is mainly explained by the increasing exposure to intermittent ultraviolet radiation Surgical excision is still the standard treatment for micronodular BCCs The costs as well as the increased workload are stressing the health care system even further and posing BCC an important health care problem Since half of the BCCs arise primarily on the face bald head and treatment by surgical excision may result in disfiguring scars patients often experience a dramatic decrease of their quality of life Hence there is an urgent medical and societal need for a simple and cheap targeted treatment preferably to be performed by the patients themselves This treatment must be safe and effective Such treatment is not available yet BCC tumorigenesis is complex and must be multifactorial Genetic alterations of multiple components of the Sonic Hedgehog SHH pathway are involved in sporadic BCC pathogenesis inactivating mutations in Patched-1 PTCH1 and activating mutations of Smoothened SMO and Suppressor of Fused SUFU With this knowledge inhibition of the SHH pathway by SMO antagonists was successfully administered however treatment resulted only in partial clinical response ofBCC Recently involvement of the Wingless Wnt pathway has been proven to be essential in BCC tumorigenic response Moreover a recent study of our own department provides the first evidence that epigenetic alterations particularly promoter hypermethylation influence both the SHH and Wnt pathway own data not published which can serve as therapeutic targets Both non-steroidal anti-inflammatory drugs NSAlDS and vitamin D derivatives are able to directly or indirectly target the Wnt pathway Furthermore vitamin D3 is able to inhibit Smoothened SMO in vitro resulting in inhibition of the SHH pathway Although in vivo studies are lacking the investigators assume that topical application of these drugs may inhibit BCC growth andor may cure BCC and thus might provide very promising future perspectives Calcitriol and NSAlDs ointments are both already available for other indications and save in use Eventually our approach may result in a systematic approach to BCC targeting epigenetic changes to treat andor prevent further tumour growth
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None