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

January 12, 2015 updated by: Maastricht University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202 AZ
        • Maastricht University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No treatment
Active Comparator: Solaraze
Drug: Diclofenac
Application on the lesion 2 times a day 8 weeks.
Other Names:
  • Solaraze
Active Comparator: Solaraze + Silkis
Drug: Diclofenac + Calcitriol
Application on the lesion 2 times a day, both ointments, 8 weeks.
Other Names:
  • Solaraze + Silkis
Active Comparator: Silkis
Drug: Calcitriol
Application on the lesion, 2 times a day, 8 weeks.
Other Names:
  • Silkis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and after 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 8 weeks.
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.
8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

May 19, 2011

First Posted (Estimate)

May 23, 2011

Study Record Updates

Last Update Posted (Estimate)

January 13, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 10-2-088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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