CoMet: Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses
Sponsor
Galderma R&D (Industry)
Overall Status
Completed
CT.gov ID
NCT01475071
Collaborator
(none)
100
6
2
12
16.7
1.4
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
100 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official 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.
Study Start Date
:
Mar 1, 2012
Actual Primary Completion Date
:
Nov 1, 2012
Actual Study Completion Date
:
Mar 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Metvix and daylight
|
Drug: 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.
|
| Active Comparator: Metvix and lamp
|
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- Lesion Response [Week12]
Percent of lesions treated at Baseline, in complete response at Week 12
- Pain Score [Baseline (during procedure), assessed after procedure]
Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female above 18 years;
-
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);
Exclusion Criteria:
-
Subject with clinical diagnosis of at least one severe AK on TAs
-
Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
-
Subject with pigmented AK on the TAs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Galderma Investigational site | Phillip | Australian Capital Territory | Australia | |
| 2 | Galderma Investigational Site | Kogarah | New South Wales | Australia | |
| 3 | Galderma Investigational site | Sydney | New South Wales | Australia | |
| 4 | Galderma Investigational site | Westmead | New South Wales | Australia | |
| 5 | Galderma Investigational site | Woolloongabba | Queensland | Australia | |
| 6 | Galderma Investigational site | Carlton | Victoria | Australia |
Sponsors and Collaborators
- Galderma R&D
Investigators
- Principal Investigator: Stephen Shumack, St George Dermatology and skin Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01475071
Other Study ID Numbers:
- RD.03.SPR.29102
First Posted:
Nov 21, 2011
Last Update Posted:
Feb 18, 2021
Last Verified:
Mar 1, 2016
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 100 subjects recruited from March 2012 to May 2012 in private practice and clinic. |
|---|---|
| Pre-assignment Detail | No significant events |
| Arm/Group Title | All Subjects Enrolled |
|---|---|
| Arm/Group Description | Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side |
| Period Title: Overall Study | |
| STARTED | 100 |
| COMPLETED | 92 |
| NOT COMPLETED | 8 |
Baseline Characteristics
| Arm/Group Title | All Subjects Enrolled |
|---|---|
| Arm/Group Description | Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side |
| Overall Participants | 100 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
41
41%
|
| >=65 years |
59
59%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
66.9
(10.5)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
25
25%
|
| Male |
75
75%
|
| Region of Enrollment (participants) [Number] | |
| Australia |
100
100%
|
Outcome Measures
| Title | Lesion Response |
|---|---|
| Description | Percent of lesions treated at Baseline, in complete response at Week 12 |
| Time Frame | Week12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only Per Protocol subjects are included in this analysis |
| Arm/Group Title | Metvix and Daylight | Metvix and Lamp |
|---|---|---|
| Arm/Group Description | Metvix and daylight Photodynamic Therapy | Metvix and conventional Phototodynamic Therapy |
| Measure Participants | 90 | 90 |
| Mean (Standard Deviation) [percentage of lesions complete response] |
89.2
(15.0)
|
92.8
(14.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Metvix and Daylight, Metvix and Lamp |
|---|---|---|
| Comments | The primary purpose of this study is to demonstrate the non-inferiority of Metvix and daylight compared to Metvix and the lamp in terms of lesion complete response rate. | |
| Type of Statistical Test | Non-Inferiority or Equivalence (legacy) | |
| Comments | Non inferiority margin of -10% | |
| Statistical Test of Hypothesis | p-Value | 0.0345 |
| Comments | ||
| Method | paired Student's t statistic | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -3.5 | |
| Confidence Interval |
(1-Sided) 95% -6.8 to |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 15.6 |
|
| Estimation Comments | ||
| Title | Pain Score |
|---|---|
| Description | Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain) |
| Time Frame | Baseline (during procedure), assessed after procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population |
| Arm/Group Title | Metvix and Daylight | Metvix and Lamp |
|---|---|---|
| Arm/Group Description | Metvix and daylight Photodynamic Therapy | Metvix and conventional Phototodynamic Therapy |
| Measure Participants | 99 | 99 |
| Mean (Standard Deviation) [units on a scale] |
0.8
(1.2)
|
5.7
(2.3)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Metvix and Daylight, Metvix and Lamp |
|---|---|---|
| Comments | superiority of Metvix adaylight and Metvix Lamp in term of pain | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | two-sided Wilcoxon rank signed | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -4.9 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Standard Deviation Value: 2.7 |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | From baseline to study end. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Metvix and Daylight | Metvix and Lamp | ||
| Arm/Group Description | Metvix and daylight Photodynamic Therapy | Metvix and conventional Phototodynamic Therapy | ||
All Cause Mortality |
||||
| Metvix and Daylight | Metvix and Lamp | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Metvix and Daylight | Metvix and Lamp | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/100 (9%) | 9/100 (9%) | ||
| Cardiac disorders | ||||
| acute coronary syndrome | 1/100 (1%) | 1 | 1/100 (1%) | 1 |
| coronary artery disease | 1/100 (1%) | 1 | 1/100 (1%) | 1 |
| Gastrointestinal disorders | ||||
| inguinal hernia | 1/100 (1%) | 1 | 1/100 (1%) | 1 |
| haemorrhoids | 1/100 (1%) | 1 | 1/100 (1%) | 1 |
| Infections and infestations | ||||
| diverticulitis | 1/100 (1%) | 1 | 1/100 (1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| rotator cuff syndrome | 1/100 (1%) | 1 | 1/100 (1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| gastroinstestinal carcinoma | 1/100 (1%) | 1 | 1/100 (1%) | 1 |
| prostate cancer | 1/100 (1%) | 1 | 1/100 (1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| pulmonary embolism | 1/100 (1%) | 1 | 1/100 (1%) | 1 |
| Vascular disorders | ||||
| deep vein thrombosis | 1/100 (1%) | 1 | 1/100 (1%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Metvix and Daylight | Metvix and Lamp | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 39/100 (39%) | 59/100 (59%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| squamous cell carcinoma | 6/100 (6%) | 8 | 6/100 (6%) | 8 |
| Skin and subcutaneous tissue disorders | ||||
| erythema | 2/100 (2%) | 2 | 5/100 (5%) | 5 |
| pain of skin | 4/100 (4%) | 4 | 6/100 (6%) | 6 |
| photosensitivity reaction | 5/100 (5%) | 5 | 10/100 (10%) | 10 |
| scab | 9/100 (9%) | 9 | 9/100 (9%) | 9 |
| skin reaction | 24/100 (24%) | 39 | 30/100 (30%) | 41 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Disclosure agreement covered by contract.
Results Point of Contact
| Name/Title | Cyril Moulin |
|---|---|
| Organization | Galderma |
| Phone | +33 4 92 38 30 14 |
| cyril.moulin@galderma.com |
Responsible Party:
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01475071
Other Study ID Numbers:
- RD.03.SPR.29102
First Posted:
Nov 21, 2011
Last Update Posted:
Feb 18, 2021
Last Verified:
Mar 1, 2016