Trial Outcomes & Findings for Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2%HAL With 16%MAL (NCT NCT02149342)

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

PHASE1/PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Baseline, 3 months

Results posted on

2016-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Hexylaminolaevulinate and Methylaminoalevulinate Creams 0,2% hexylaminolaevulinate cream , HAL (Hexvix, Photocure, Unguentum M, Almirall) 16% methylaminolaevulinate, MAL (Metvix, Galderma) HAL and MAL used as photosensitizer for daylight-PDT in a randomized split-face design
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Daylight-mediated Photodynamic Therapy of Actinic Keratoses:Comparing 0.2%HAL With 16%MAL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hexylaminolaevulinate and Methylaminoalevulinate Cream n=14 Participants 0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and 16% methylaminolaevulinate (Metvix, Galderma) in a split-face design
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	79 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment Finland	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: One patient was excluded from the histological analysis because one biopsied lesion clinically taken as an AK appeared histologically to be seborrheic eczema.

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	Hexylaminolaevulinate Cream n=26 Punch biopsies 0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream	Methylaminolaevulinate Cream n=26 Punch biopsies 16% methylaminolaevulinate (Metvix, Galderma) Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT
Histological Lesion Clearance	38.5 percentage of complete histological clea Interval 0.0 to 100.0	69.2 percentage of complete histological clea Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: Baseline, 3 months

Clinical lesion clearance is observed by a blinded observer

Outcome measures

Outcome measures
Measure	Hexylaminolaevulinate Cream n=103 AK lesions 0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream	Methylaminolaevulinate Cream n=98 AK lesions 16% methylaminolaevulinate (Metvix, Galderma) Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT
Clinical Lesion Clearance	73.4 percentage of lesions in complete respon Interval 28.6 to 100.0	77.8 percentage of lesions in complete respon Interval 44.4 to 100.0

SECONDARY outcome

Timeframe: One week

Adverse reactions are evaluated by blinded observer at one week after treatment. Severity of the reaction ( Redness, crusting and scaling) is assessed using grading: minimal, mild, intermediate, severe.

Outcome measures

Outcome measures
Measure	Hexylaminolaevulinate Cream n=14 Participants 0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream	Methylaminolaevulinate Cream n=14 Participants 16% methylaminolaevulinate (Metvix, Galderma) Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT
Adverse Reactions	14 participants	14 participants

SECONDARY outcome

Timeframe: 12 hours

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	Hexylaminolaevulinate Cream n=14 Participants 0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream	Methylaminolaevulinate Cream n=14 Participants 16% methylaminolaevulinate (Metvix, Galderma) Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT
Pain Assesment (Visual Analog Scale)	0.86 Mean maximal pain VAS score Interval 0.1 to 2.2	1 Mean maximal pain VAS score Interval 0.1 to 4.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Data not collected

Outcome measures

Outcome data not reported

Adverse Events

Hexylaminolaevulinate Cream

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Methylaminolaevulinate Cream

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hexylaminolaevulinate Cream n=14 participants at risk 0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015) Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)	Methylaminolaevulinate Cream n=14 participants at risk 16% methylaminolaevulinate (Metvix, Galderma) Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT
Skin and subcutaneous tissue disorders Redness, crusting, scaling; minimal	71.4% 10/14 • Number of events 10 • Adverse reactions were assessed by blinded observer at one week after treatment Cosmetic outcome was evaluated at 3 months	21.4% 3/14 • Number of events 3 • Adverse reactions were assessed by blinded observer at one week after treatment Cosmetic outcome was evaluated at 3 months
Skin and subcutaneous tissue disorders Redness, scaling, crusting; Mild	21.4% 3/14 • Number of events 3 • Adverse reactions were assessed by blinded observer at one week after treatment Cosmetic outcome was evaluated at 3 months	64.3% 9/14 • Number of events 9 • Adverse reactions were assessed by blinded observer at one week after treatment Cosmetic outcome was evaluated at 3 months
Skin and subcutaneous tissue disorders Redness, crusting, scaling; intermediate	7.1% 1/14 • Number of events 1 • Adverse reactions were assessed by blinded observer at one week after treatment Cosmetic outcome was evaluated at 3 months	14.3% 2/14 • Number of events 2 • Adverse reactions were assessed by blinded observer at one week after treatment Cosmetic outcome was evaluated at 3 months
Skin and subcutaneous tissue disorders Redness, scaling, crusting; Severe	0.00% 0/14 • Adverse reactions were assessed by blinded observer at one week after treatment Cosmetic outcome was evaluated at 3 months	0.00% 0/14 • Adverse reactions were assessed by blinded observer at one week after treatment Cosmetic outcome was evaluated at 3 months

Additional Information

Md, PhD Noora Neittaanmäki-Perttu

Helsinki university central hospital

Phone: +358407190362

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place