Trial Outcomes & Findings for PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK (NCT NCT03511326)

NCT ID: NCT03511326

Last Updated: 2021-02-18

Results Overview

Percentage of subjects satisfied and very satisfied globally with Luxerm Daylight procedure, the day of treatment after daylight session

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 50 participants
• Primary outcome timeframe: the day of treatment after daylight session
• Results posted on: 2021-02-18

Participant Flow

Participant milestones

Measure	Luxerm® Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
Overall Study STARTED	50
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Luxerm® Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
Overall Study Withdrawal by Subject	1

Baseline Characteristics

PRO With Luxerm® in the Field Treatment of Thin and Non-hyperkeratotic Non-pigmented AK

Baseline characteristics by cohort

Measure	Luxerm® n=50 Participants Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	41 Participants n=5 Participants
Age, Continuous	73.4 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Germany	50 participants n=5 Participants
Skin phototype Phototype I	7 Participants n=5 Participants
Skin phototype Phototype II	35 Participants n=5 Participants
Skin phototype Phototype III	8 Participants n=5 Participants
Duration of Actinic Keratosis	7.77 years STANDARD_DEVIATION 6.78 • n=5 Participants

PRIMARY outcome

Timeframe: the day of treatment after daylight session

Population: Intent to Treat (ITT) population included all enrolled participants (i.e. treatment dispensed).

Percentage of subjects satisfied and very satisfied globally with Luxerm Daylight procedure, the day of treatment after daylight session

Outcome measures

Measure	Luxerm® n=50 Participants Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
Overall Subject Satisfaction the Day of Treatment After Daylight Session	47 Participants

PRIMARY outcome

Timeframe: Week 12

Population: ITT population included all enrolled participants (i.e. treatment dispensed). Here, the "N" number of participants analyzed signifies participants who were evaluable for this outcome measure.

Percentage of subjects satisfied or very satisfied (overall) with Luxerm DL procedure

Outcome measures

Measure	Luxerm® n=48 Participants Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
Overall Subject Satisfaction at Week 12 Post-treatment	41 Participants

Adverse Events

Luxerm®

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Luxerm® n=50 participants at risk Methyl Aminolaevulinate 16% Cream: Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
Injury, poisoning and procedural complications Procedural pain	30.0% 15/50 • Number of events 15 • From signing of Informed Consent Form (ICF) to end of study (Week 12)
Skin and subcutaneous tissue disorders Erythema	38.0% 19/50 • Number of events 20 • From signing of Informed Consent Form (ICF) to end of study (Week 12)
Skin and subcutaneous tissue disorders Pruritus	2.0% 1/50 • Number of events 1 • From signing of Informed Consent Form (ICF) to end of study (Week 12)
Skin and subcutaneous tissue disorders Skin burning sensation	16.0% 8/50 • Number of events 8 • From signing of Informed Consent Form (ICF) to end of study (Week 12)
Skin and subcutaneous tissue disorders Skin discolouration	2.0% 1/50 • Number of events 1 • From signing of Informed Consent Form (ICF) to end of study (Week 12)
Skin and subcutaneous tissue disorders Skin exfoliation	2.0% 1/50 • Number of events 1 • From signing of Informed Consent Form (ICF) to end of study (Week 12)
Skin and subcutaneous tissue disorders Skin irritation	2.0% 1/50 • Number of events 1 • From signing of Informed Consent Form (ICF) to end of study (Week 12)
Skin and subcutaneous tissue disorders Skin tightness	2.0% 1/50 • Number of events 1 • From signing of Informed Consent Form (ICF) to end of study (Week 12)
Skin and subcutaneous tissue disorders Skin warm	2.0% 1/50 • Number of events 1 • From signing of Informed Consent Form (ICF) to end of study (Week 12)
Infections and infestations Rhinitis	2.0% 1/50 • Number of events 1 • From signing of Informed Consent Form (ICF) to end of study (Week 12)
Infections and infestations Wound infection	2.0% 1/50 • Number of events 1 • From signing of Informed Consent Form (ICF) to end of study (Week 12)

Additional Information

CTA Coordinator

Galderma R&D SNC

Phone: +33 0493 95 70 85

Email: cta.coordinator@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place