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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Basal Cell Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Histological changes in different proliferation, apoptosis and autophagy markers.

Outcome Description:

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).

Outcome Time Frame:

At baseline and after 8 weeks.

Safety Issue:

No

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

MEC 10-2-088

NCT ID:

NCT01358045

Start Date:

November 2011

Completion Date:

May 2013

Related Keywords:

  • Basal Cell Carcinoma
  • Topical
  • Diclofenac
  • Vitamin D3
  • Carcinoma
  • Carcinoma, Basal Cell

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