Trial Outcomes & Findings for Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL) (NCT NCT01893203)

Results Overview

Punch biopsies were taken symmetrically on both treatment fields from equally graded \>6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (\<10 % normal)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

14 participants

Primary outcome timeframe

0 (baseline) and 3 months

Results posted on

2016-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	BF200 ALA vs MAL 5-aminulevulinic acid nanoemulsion (BF-200 ALA, Ameluz, Biofrontera) and methylaminolevulinic acid (MAL, Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
Overall Study STARTED	14
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	BF200 ALA vs MAL 5-aminulevulinic acid nanoemulsion (BF-200 ALA, Ameluz, Biofrontera) and methylaminolevulinic acid (MAL, Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Daylight-PDT for AKs: Comparing Two Photosensitizers (BF-200 ALA and MAL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BF-200 ALA vs MAL n=13 Participants BF-200 ALA cream and MAL (Metvix, Galderma) used in a randomized split-face design
Age, Continuous	79.8 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Number of AKs	177 Number of actinic keratoses (AKs) n=5 Participants

PRIMARY outcome

Timeframe: 0 (baseline) and 3 months

Population: Punch biopsies bilaterally on treatment fields

Punch biopsies were taken symmetrically on both treatment fields from equally graded \>6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (\<10 % normal)

Outcome measures

Outcome measures
Measure	BF200 ALA vs MAL n=13 Participants BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
Histological Lesion Clearance BF-200 ALA	61.5 percentage of complete clearance
Histological Lesion Clearance MAL	38.5 percentage of complete clearance

SECONDARY outcome

Timeframe: 12 hours

Population: Patients

Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m. (treatment day). Of these values, the mean maximal pain is assessed.

Outcome measures

Outcome measures
Measure	BF200 ALA vs MAL n=13 Participants BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
Pain BF-200 ALA treatment sides	1.7 units on a scale Interval 0.4 to 8.6
Pain MAL treatment sides	1.9 units on a scale Interval 0.2 to 8.6

SECONDARY outcome

Timeframe: 3 months

Clinical lesion clearance is observed by a blinded observer

Outcome measures

Outcome measures
Measure	BF200 ALA vs MAL n=177 AKs total BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
Clinical Lesion Clearance BF-200 ALA treated lesions	84.5 percentage of complete clearance Interval 75.2 to 90.9
Clinical Lesion Clearance MAL treated lesions	74.2 percentage of complete clearance Interval 64.4 to 82.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 week

Population: One week after the first photodynamic therapy (PDT), seven patients had more severe reactions (erythema, crusting) at the site treated with BF-200 ALA, five patients had more severe reactions at the MAL site and one patient showed no difference between sites.

Adverse reactions are evaluated by blinded observer at one week after treatment. A dermatologist will assess which side of the face or scalp presents a stronger reaction.

Outcome measures

Outcome measures
Measure	BF200 ALA vs MAL n=13 Participants BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
Adverse Reactions BF-200 ALA treated areas	7 participants
Adverse Reactions MAL treated areas	5 participants
Adverse Reactions No difference between the sides	1 participants

Adverse Events

BF200 ALA vs MAL

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BF200 ALA vs MAL n=13 participants at risk BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized slipt face design on symmetrical treatment areas.
Skin and subcutaneous tissue disorders Adverse reactions: erythema, crusting, scaling	100.0% 13/13 • Number of events 13
Skin and subcutaneous tissue disorders Pain	100.0% 13/13 • Number of events 13

Additional Information

Noora Neittaanmäki-Perttu

Helsinki university hospital

Phone: +358407190362

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place