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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01358045
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE May 17, 2011
First Posted Date  ICMJE May 23, 2011
Last Update Posted Date January 13, 2015
Study Start Date  ICMJE November 2011
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2011)
Histological changes in different proliferation, apoptosis and autophagy markers. [ Time Frame: At baseline and after 8 weeks. ]
To determine whether topical application of Calcitriol (Silkis) 3 μg/g, Diclofenac 3% or a combination of both can lead to a 40% histological reduction (↓)/increase (↑) of expression of the following antibodies: Ki67 (↓), BCL2 (↓), CASPASE 3 (↑) and Cox2 (↓) (proliferation and apoptosis), LC3B (↑) (autophagy), HIF1α (↓) (hypoxia), β-catenin (↓), sFRP4 (↑) and sFRP5 (↑) (Wnt pathway activity).
Change History Complete list of historical versions of study NCT01358045 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2011)
  • 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 coulour.
  • 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.
  • Safety [ Time Frame: 8 weeks ]
    We want to evaluate if the treatment is safe and doesn't lead to al lot of side effects.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma
Official Title  ICMJE Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Basal Cell Carcinoma
Intervention  ICMJE
  • Drug: Diclofenac
    Application on the lesion 2 times a day 8 weeks.
    Other Name: Solaraze
  • Drug: Diclofenac + Calcitriol
    Application on the lesion 2 times a day, both ointments, 8 weeks.
    Other Name: Solaraze + Silkis
  • Drug: Calcitriol
    Application on the lesion, 2 times a day, 8 weeks.
    Other Name: Silkis
Study Arms  ICMJE
  • Active Comparator: Solaraze
    Intervention: Drug: Diclofenac
  • Active Comparator: Solaraze + Silkis
    Intervention: Drug: Diclofenac + Calcitriol
  • Active Comparator: Silkis
    Intervention: Drug: Calcitriol
  • No Intervention: No treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2012)
128
Original Estimated Enrollment  ICMJE
 (submitted: May 19, 2011)
64
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01358045
Other Study ID Numbers  ICMJE MEC 10-2-088
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Maastricht University Medical Center
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP