Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma

NCT ID: NCT01358045

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-05-31

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 (micro)nodular 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 (SU(FU)). 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 and/or 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 (epi)genetic changes to treat and/or prevent further tumour growth.

Conditions

Basal Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Solaraze

Group Type: ACTIVE_COMPARATOR

Diclofenac

Intervention Type: DRUG

Application on the lesion 2 times a day 8 weeks.

Solaraze + Silkis

Group Type: ACTIVE_COMPARATOR

Diclofenac + Calcitriol

Intervention Type: DRUG

Application on the lesion 2 times a day, both ointments, 8 weeks.

Silkis

Group Type: ACTIVE_COMPARATOR

Calcitriol

Intervention Type: DRUG

Application on the lesion, 2 times a day, 8 weeks.

No treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Diclofenac

Application on the lesion 2 times a day 8 weeks.

Intervention Type: DRUG

Diclofenac + Calcitriol

Application on the lesion 2 times a day, both ointments, 8 weeks.

Intervention Type: DRUG

Calcitriol

Application on the lesion, 2 times a day, 8 weeks.

Intervention Type: DRUG

Other Intervention Names

Solaraze; Solaraze + Silkis; Silkis

Eligibility Criteria

Inclusion Criteria

• Minimum age 18 years
• Primary basal cell carcinoma, histologically confirmed
• (Micro) Nodular or superficial histological subtype
• Comorbidities may not interfere with study treatment
• Capable to understand instructions

Exclusion Criteria

• Age under 18 years
• Tumors located at the H-zone of the face
• Deficient histological conformation
• Proven or suspected malignancy of other organs
• Not capable of comprehending instructions
• Incompetent
• Use of oral NSAlDs during the trial period or within 30 days before starting therapy
• Use of oral vitamin D (containing) supplements during the trial period or within 30 days before starting therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Countries

Netherlands

Other Identifiers

MEC 10-2-088

Identifier Type: -

Identifier Source: org_study_id