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Topical Green Tea Ointment in Treatment of Superficial Skin Cancer

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ClinicalTrials.gov Identifier: NCT02029352
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : May 18, 2016
Sponsor:
Collaborators:
Will-Pharma
Medigene AG
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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Brief Summary:

Basal cell carcinoma (BCC) is the most frequently occurring nonmelanoma skin cancer in Caucasians, representing approximately 80% of cases. Incidence rates for men and women in the Netherlands are 165 and 157 per 100,000 person-years respectively and are still rising 3-10% annually. In 2009, the lifetime risk for developing a first histologically confirmed BCC for men was approximately 1 in 5 (21%) and for women it was 1 in 6 (18%).

A simplified classification of BCC includes the following three histological subtypes: nodular (40,6), superficial (30,7%) and infiltrative BCC (28,7%). Superficial BCCs (sBCCs) differ from the other subtypes as they tend to appear at a younger age, usually occur on the trunk and are often multiple. This subtype has the fastest growing incidence.

A characteristic feature of BCCs is their low risk to metastasize, though if untreated they may induce considerable functional and cosmetic morbidity as they are locally invasive. Surgery is the first treatment of choice for BCC. However due to the rising incidence and the extensive workload this entails, a non-invasive topical treatment is often chosen for sBCC as they grow down from the epidermis into the superficial dermis and therefore are easily accessible for topical treatment. Photodynamic therapy (PDT), imiquimod cream or 5-fluorouracil cream are available topical treatments for sBCC however their tumour free survival rates are not equal to the higher tumour free survival rates of surgical treatment. Next to the efficacy, the now available topical treatments are associated with local skin reactions at the treatment site, mainly erythema and erosion (imiquimod cream and 5-fluorouracil cream) or pain and burning sensation (PDT). This creates the need for additional or alternative non-invasive topical treatments.

The active constituents of green tea are promising as they are supported to have anti-BCC-carcinogenesis effects by several epidemiological, cell culture and animal studies. The so-called polyphenols known as catechins are the active constituents of green tea and the catechin epigallocatechin-3-gallate (EGCG) is the major and most active catechin. EGCG is thought to have a cytotoxic effect on skin cancer cells and has the availability of inhibition of cell growth and induction of apoptosis. It is also suggested that EGCG plays a role in inactivation of β-catenin signalling, an important component of the WNT pathway.

Sinecatechins 10% ointment (Veregen®) is a standardized extract of green tea leaves of the species Camellia sinensis, containing mainly green tea polyphenols, particularly catechins (more than 85%). The lead catechin in sinecatechins ointment is EGCG. It is approved by the US Food and Drug Administration (FDA) for genital warts in adults.

There are no clinical trials on human subjects with topical EGCG on sBCC yet. With this trial we are the first to try to validate the anti-carcinogenic potentials of topical EGCG in humans with sBCC. We assess the effectiveness of sinecatechins 10% (Veregen®) versus placebo for the topical treatment of sBCCs.


Condition or disease Intervention/treatment Phase
Carcinoma, Basal Cell Drug: Sinecatechins 10% Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Topical Sinecatechins Ointment in Treatment of Primary Superficial Basal Cell Carcinoma: a Double Blind, Randomized, Placebo-controlled Trial.
Study Start Date : November 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sinecatechins 10%
Patients are instructed to apply a thin layer of the sinecatechins 10% ointment twice daily (morning and evening) in a thin layer to the tumour including 5mm of the surrounding skin. Before applying a new layer patients are advised to wipe off the remnants. Sinecatechins 10% ointment has to be applied for six weeks. Patients are advised to wash their hands after each application to prevent spreading of the ointment.
 Drug: Sinecatechins 10%
Other Name: Veregen
Placebo Comparator: Placebo
Patients are instructed to apply a thin layer of the placebo ointment twice daily (morning and evening) in a thin layer to the tumour including 5mm of the surrounding skin. Before applying a new layer patients are advised to wipe off the remnants. Sinecatechins 10% ointment has to be applied for six weeks. Patients are advised to wash their hands after each application to prevent spreading of the ointment.
 Drug: Placebo
Composition, apart from the active substance, is otherwise identical to the investigational medical product.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients with complete histological clearance [ Time Frame: After 6 weeks treatment ]
    Therapeutic surgical excision of the target tumour will be performed eight weeks after start of study treatment, for histological evaluation of response.


Secondary Outcome Measures :
  1. Number of applications actually done by the patient divided by the total prescribed number of applications. [ Time Frame: Week 6 ]
  2. Number of local skin reactions, adverse events and serious adverse events [ Time Frame: Up to 3 weeks ]

    Objective local skin signs (ie. Erythema, edema, induration, vesicles, erosion/ulceration, or other) will be assessed by the investigator at 3, 6 and 8 weeks after start of treatment.

    Subjective symptoms (ie. Pain, burning, itching, or other) will be assessed from a personal diary kept by patients once a week during treatment.

    Adverse events other than local skin reactions at the application site reported by the patient will be assessed according to the same grading.

    Other adverse events or (suspected) (unexpected) serious adverse events will be recorded by the investigator.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults aged 18 years or older
  • Primary histological proven superficial basal cell carcinoma ≥ 4mm and ≤ 20mm
  • Comorbidities may not interfere with study treatment (evaluated by investigator)
  • Capable to understand instructions

Exclusion Criteria:

  • Recurrent sBCC (previous treatment)
  • Breast-feeding or pregnant women
  • Serious comorbidities
  • Use of immunosuppressive medication during the trial period or within 30 days before enrolment
  • Patients with genetic skin cancer disorders
  • Tumour located in the H zone (high-risk area of face) or scalp
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029352


Locations
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Netherlands
Maastricht University Medical Centre
Maastricht, Limburg, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Will-Pharma
Medigene AG
Investigators
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Principal Investigator: Nicole WJ Kelleners-Smeets, MD, PhD Maastricht University Hospital
More Information
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Publications:

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02029352    
Other Study ID Numbers: NL47392.068.13
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: June 2015
Keywords provided by Maastricht University Medical Center:
Treatment
Sinecatechins
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell