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Trial registered on ANZCTR
Registration number
ACTRN12613000207718
Ethics application status
Approved
Date submitted
15/02/2013
Date registered
21/02/2013
Date last updated
22/02/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
Dermoscopy for monitoring therapeutic response to non-surgical treatments of in-situ squamous cell carcinoma.
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Scientific title
Applicability of dermoscopy for evaluation of the effectiveness of Imiquimod cream, Photodynamic therapy and Cryotherapy in the treatment of actinic keratosis and Bowen's disease.
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Secondary ID [1]
281974
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NIL
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Actinic Keratosis
288400
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Bowen's Disease
288401
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Condition category
Condition code
Cancer
288749
288749
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0
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Non melanoma skin cancer
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Cancer
288750
288750
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0
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Non melanoma skin cancer
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Identify specific dermoscopic features of biopsy proven Actinic Keratosis and Bowen's Disease before and after treatment with Imiquimod cream or Photodynamic therapy or cryotherapy in order to specify the presence or not of residual disease. Actinic keratosis will be treated either with 1 freeze thaw cycle of cryotherapy with liquid nitrogen OR2 sessions of methylaminolevulinate PDT (MAL-PDT, Metvix PDT), one week apart,or imiquimod cream applied 3 days/week for 12 weeks.Bowen’s disease will be treated with 2 freeze-thaw cycles of cryotherapy or 2 sessions of MAL-PDT, one week apart or imiquimod 5% cream applied 5 days/week for 12 week. Dermoscopic evaluation will be performed at baseline, 4 and 12 weeks after last treatment intervention. Participants will be observed in total for their treatment period and for 12 weeks after their last treatment intervention.
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Intervention code [1]
286543
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Not applicable
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Comparator / control treatment
Not applicable, because the primary outcome of this trial is the evaluation of dermoscopy as diagnosting tool for the identfication of residual disease after application of non-surgical treatments (i.e cryotherapy, PDT, or imiquimod cream) for in-situ squamous cell carcinomas. The effectiveness of these treatments is not evaluated in this trial. In that sense we do not need a control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Primary outcome is to identify whether certain dermoscopic criteria can predict the presence or absense of residual disease after non surgical treatment (imiquimod cream , phodynamic treatment or cryotherapy) of in situ squamous cell carcinomas (actinic keratosis and Bowen's disease) with sufficient sensitivity and specificity.
At baseline each lesion (actinic keratosis or Bowen's disease) will be examined with a Dermlite (3 GEN) handheld dermatoscope and clinical and dermoscopic pictures will be taken with an attached photo camera. All dermoscopic findings will be recorded. A biopsy of the lesion will be performed at the time to confirm diagnosis.
A month after the initiation of treatment for each lesion clinical and dermoscopic evaluations will be performed and clinical and dermoscopic poctures will be taken.
Three months after the initiation of treatment all lesions will be clinically and demoscopically assessed and pictures will be taken. The dermoscopic findings of each timepoint will be compared and evaluated by 2 indipendent dermoscopists. A final biopsy at this timepoint will confirm the presenseor not of residual disease and the histopathological findings will be compared with the dermoscopic ones.
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Assessment method [1]
288891
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Timepoint [1]
288891
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DERMOSCOPIC EVLUATION at baseline and 1and 3 months after the last treatment session of each treatment modality all lesions will be clinically and dermoscopically reevaluated and changes will be photographically documented.
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Secondary outcome [1]
301249
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Nil
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Assessment method [1]
301249
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Timepoint [1]
301249
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nil
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Eligibility
Key inclusion criteria
18 years of age
Biopsy proven actinic keratosis or Bowen's disease
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
pregnancy and lactation
History of hypersensitivity in imiquimod or amilevulinate acid
photosensitivity for Photodynamic therapy group
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
25/02/2013
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
4869
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Greece
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State/province [1]
4869
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Funding & Sponsors
Funding source category [1]
286751
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University
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Name [1]
286751
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Aristotle University of Thessaloniki
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Address [1]
286751
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124 Delfon Street, 54643, Thessaloniki, Greece
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Country [1]
286751
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Greece
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Primary sponsor type
University
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Name
Aristotle University of Thessaloniki
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Address
124 Delfon Street, 54643, Thessaloniki, Greece
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Country
Greece
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Secondary sponsor category [1]
285531
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University
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Name [1]
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Aristotle University of Thessaloniki
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Address [1]
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124 Delfon Street, 54643, Thessaloniki, Greece
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Country [1]
285531
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Greece
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
Primary purpose is to identify whether certain dermoscopic criteria can predict the presence or absense of residual disease after non surgical treatment (miquimod cream , phodynamic treatment or cryotherapy) of in situ squamous cell carcinomas (actinic keratosis and Bowen's disease) with sufficient sensitivity and specificity
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
37930
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A/Prof Elisavet Lazaridou
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Address
37930
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124 Delfon Street, 54643, Thessaloniki, Greece
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Country
37930
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Greece
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Phone
37930
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+302313308894
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Fax
37930
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Email
37930
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[email protected]
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Contact person for public queries
Name
37931
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Elisavet Lazaridou
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Address
37931
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124 Delfon Street, 54643, Thessaloniki, Greece
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Country
37931
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Greece
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Phone
37931
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+302313308894
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Fax
37931
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Email
37931
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[email protected]
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Contact person for scientific queries
Name
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Elisavet Lazaridou
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Address
37932
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124 Delfon Street, 54643, Thessaloniki, Greece
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Country
37932
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Greece
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Phone
37932
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+302313308894
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Fax
37932
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Email
37932
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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