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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01475071




Registration number
NCT01475071
Ethics application status
Date submitted
27/10/2011
Date registered
21/11/2011
Date last updated
18/02/2021

Titles & IDs
Public title
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
Scientific title
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses.
Secondary ID [1] 0 0
RD.03.SPR.29102
Universal Trial Number (UTN)
Trial acronym
CoMet
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Actinic Keratoses 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Metvix and natural daylight PDT
Treatment: Drugs - Metvix and conventional PDT

Experimental: Metvix and daylight -

Active Comparator: Metvix and lamp -


Treatment: Drugs: Metvix and natural daylight PDT
Methyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.

Treatment: Drugs: Metvix and conventional PDT
Methyl aminolevulinate, cream, 160mg/g. One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Lesion Response
Timepoint [1] 0 0
Week12
Primary outcome [2] 0 0
Pain Score
Timepoint [2] 0 0
Baseline (during procedure), assessed after procedure

Eligibility
Key inclusion criteria
1. Male or female above 18 years;

2. Subject with clinical diagnosis of mild AK on the face or the scalp with or without
clinical diagnosis of moderate AK on the target areas (TAs);
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject with clinical diagnosis of at least one severe AK on TAs

2. Subject with clinical diagnosis of other skin disease (including non-melanoma skin
cancer) on the TAs;

3. Subject with pigmented AK on the TAs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Galderma Investigational site - Phillip
Recruitment hospital [2] 0 0
Galderma Investigational Site - Kogarah
Recruitment hospital [3] 0 0
Galderma Investigational site - Sydney
Recruitment hospital [4] 0 0
Galderma Investigational site - Westmead
Recruitment hospital [5] 0 0
Galderma Investigational site - Woolloongabba
Recruitment hospital [6] 0 0
Galderma Investigational site - Carlton
Recruitment postcode(s) [1] 0 0
- Phillip
Recruitment postcode(s) [2] 0 0
- Kogarah
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
- Westmead
Recruitment postcode(s) [5] 0 0
- Woolloongabba
Recruitment postcode(s) [6] 0 0
- Carlton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Galderma R&D
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main objective of this study is to compare efficacy and safety of Metvix® natural
daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with
Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01475071
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Shumack
Address 0 0
St George Dermatology and skin Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01475071