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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.
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.
Secondary ID [1] 281974 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Actinic Keratosis 288400 0
Bowen's Disease 288401 0
Condition category
Condition code
Cancer 288749 288749 0 0
Non melanoma skin cancer
Cancer 288750 288750 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 286543 0
Not applicable
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.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288891 0
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.
Timepoint [1] 288891 0
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.
Secondary outcome [1] 301249 0
Nil
Timepoint [1] 301249 0
nil

Eligibility
Key inclusion criteria
18 years of age
Biopsy proven actinic keratosis or Bowen's disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnancy and lactation
History of hypersensitivity in imiquimod or amilevulinate acid
photosensitivity for Photodynamic therapy group

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/02/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 4869 0
Greece
State/province [1] 4869 0

Funding & Sponsors
Funding source category [1] 286751 0
University
Name [1] 286751 0
Aristotle University of Thessaloniki
Country [1] 286751 0
Greece
Primary sponsor type
University
Name
Aristotle University of Thessaloniki
Address
124 Delfon Street, 54643, Thessaloniki, Greece
Country
Greece
Secondary sponsor category [1] 285531 0
University
Name [1] 285531 0
Aristotle University of Thessaloniki
Address [1] 285531 0
124 Delfon Street, 54643, Thessaloniki, Greece
Country [1] 285531 0
Greece

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37930 0
A/Prof Elisavet Lazaridou
Address 37930 0
124 Delfon Street, 54643, Thessaloniki, Greece
Country 37930 0
Greece
Phone 37930 0
+302313308894
Fax 37930 0
Email 37930 0
bethlaz@med.auth.gr
Contact person for public queries
Name 37931 0
Elisavet Lazaridou
Address 37931 0
124 Delfon Street, 54643, Thessaloniki, Greece
Country 37931 0
Greece
Phone 37931 0
+302313308894
Fax 37931 0
Email 37931 0
bethlaz@med.auth.gr
Contact person for scientific queries
Name 37932 0
Elisavet Lazaridou
Address 37932 0
124 Delfon Street, 54643, Thessaloniki, Greece
Country 37932 0
Greece
Phone 37932 0
+302313308894
Fax 37932 0
Email 37932 0
bethlaz@med.auth.gr

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.