Trial Outcomes & Findings for Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses (NCT NCT01475071)

NCT ID: NCT01475071

Last Updated: 2021-02-18

Results Overview

Percent of lesions treated at Baseline, in complete response at Week 12

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 100 participants
• Primary outcome timeframe: Week12
• Results posted on: 2021-02-18

Participant Flow

100 subjects recruited from March 2012 to May 2012 in private practice and clinic.

No significant events

Participant milestones

Measure	All Subjects Enrolled 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 Study STARTED	100
Overall Study COMPLETED	92
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	All Subjects Enrolled 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 Study Physician Decision	1
Overall Study Withdrawal by Subject	6
Overall Study Lost to Follow-up	1

Baseline Characteristics

Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses

Baseline characteristics by cohort

Measure	All Subjects Enrolled n=100 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants
Age, Categorical >=65 years	59 Participants n=5 Participants
Age, Continuous	66.9 years STANDARD_DEVIATION 10.5 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	75 Participants n=5 Participants
Region of Enrollment Australia	100 participants n=5 Participants

PRIMARY outcome

Timeframe: Week12

Population: Only Per Protocol subjects are included in this analysis

Percent of lesions treated at Baseline, in complete response at Week 12

Outcome measures

Measure	Metvix and Daylight n=90 Participants Metvix and daylight Photodynamic Therapy	Metvix and Lamp n=90 Participants Metvix and conventional Phototodynamic Therapy
Lesion Response	89.2 percentage of lesions complete response Standard Deviation 15.0	92.8 percentage of lesions complete response Standard Deviation 14.1

PRIMARY outcome

Timeframe: Baseline (during procedure), assessed after procedure

Population: ITT population

Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)

Outcome measures

Measure	Metvix and Daylight n=99 Participants Metvix and daylight Photodynamic Therapy	Metvix and Lamp n=99 Participants Metvix and conventional Phototodynamic Therapy
Pain Score	0.8 units on a scale Standard Deviation 1.2	5.7 units on a scale Standard Deviation 2.3

Adverse Events

Metvix and Daylight

Serious events: 9 serious events

Other events: 39 other events

Deaths: 0 deaths

Metvix and Lamp

Serious events: 9 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Measure	Metvix and Daylight n=100 participants at risk Metvix and daylight Photodynamic Therapy	Metvix and Lamp n=100 participants at risk Metvix and conventional Phototodynamic Therapy
Cardiac disorders acute coronary syndrome	1.0% 1/100 • Number of events 1 • From baseline to study end.	1.0% 1/100 • Number of events 1 • From baseline to study end.
Vascular disorders deep vein thrombosis	1.0% 1/100 • Number of events 1 • From baseline to study end.	1.0% 1/100 • Number of events 1 • From baseline to study end.
Respiratory, thoracic and mediastinal disorders pulmonary embolism	1.0% 1/100 • Number of events 1 • From baseline to study end.	1.0% 1/100 • Number of events 1 • From baseline to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) gastroinstestinal carcinoma	1.0% 1/100 • Number of events 1 • From baseline to study end.	1.0% 1/100 • Number of events 1 • From baseline to study end.
Musculoskeletal and connective tissue disorders rotator cuff syndrome	1.0% 1/100 • Number of events 1 • From baseline to study end.	1.0% 1/100 • Number of events 1 • From baseline to study end.
Cardiac disorders coronary artery disease	1.0% 1/100 • Number of events 1 • From baseline to study end.	1.0% 1/100 • Number of events 1 • From baseline to study end.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) prostate cancer	1.0% 1/100 • Number of events 1 • From baseline to study end.	1.0% 1/100 • Number of events 1 • From baseline to study end.
Gastrointestinal disorders inguinal hernia	1.0% 1/100 • Number of events 1 • From baseline to study end.	1.0% 1/100 • Number of events 1 • From baseline to study end.
Infections and infestations diverticulitis	1.0% 1/100 • Number of events 1 • From baseline to study end.	1.0% 1/100 • Number of events 1 • From baseline to study end.
Gastrointestinal disorders haemorrhoids	1.0% 1/100 • Number of events 1 • From baseline to study end.	1.0% 1/100 • Number of events 1 • From baseline to study end.

Other adverse events

Measure	Metvix and Daylight n=100 participants at risk Metvix and daylight Photodynamic Therapy	Metvix and Lamp n=100 participants at risk Metvix and conventional Phototodynamic Therapy
Neoplasms benign, malignant and unspecified (incl cysts and polyps) squamous cell carcinoma	6.0% 6/100 • Number of events 8 • From baseline to study end.	6.0% 6/100 • Number of events 8 • From baseline to study end.
Skin and subcutaneous tissue disorders erythema	2.0% 2/100 • Number of events 2 • From baseline to study end.	5.0% 5/100 • Number of events 5 • From baseline to study end.
Skin and subcutaneous tissue disorders pain of skin	4.0% 4/100 • Number of events 4 • From baseline to study end.	6.0% 6/100 • Number of events 6 • From baseline to study end.
Skin and subcutaneous tissue disorders photosensitivity reaction	5.0% 5/100 • Number of events 5 • From baseline to study end.	10.0% 10/100 • Number of events 10 • From baseline to study end.
Skin and subcutaneous tissue disorders scab	9.0% 9/100 • Number of events 9 • From baseline to study end.	9.0% 9/100 • Number of events 9 • From baseline to study end.
Skin and subcutaneous tissue disorders skin reaction	24.0% 24/100 • Number of events 39 • From baseline to study end.	30.0% 30/100 • Number of events 41 • From baseline to study end.

Additional Information

Cyril Moulin

Galderma

Phone: +33 4 92 38 30 14

Email: cyril.moulin@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee Disclosure agreement covered by contract.
• Publication restrictions are in place

Restriction type: OTHER