Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Methyl 5-aminolevulinate

Photosensitizing Agents

Fluoxymesterone

Aminolevulinic Acid

0.2% HAL (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and MAL (Metvix, Galderma) used in a randomized split-face design

0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)

Hexylaminolaevulinate cream

MAL 16% is used as photosensitizer for daylight-PDT

Methylaminolaevulinate cream

Noora E Neittaanmäki-Perttu, MD

Mari Grönroos, MD, PhD

This pilot study compares two photosensitizers, hexylaminolaevulinate (HAL) and methylaminolaevulinate (MAL), in treatment of actinic keratoses. Study is conducted using randomized split-face design. Efficacy is assessed clinically, and histologically at 3 and 12 months. Pain during and after treatments and adverse reactions at one week are recorded.

Study recruites 16-20 voluuntering patients with symmetrical actinic damage on face or scalp. Treatment sites are randomized to receive either hexylaminolaevulinate 0.2% or methylaminolaevulinate ( 16% MAL) as photosensitizers (0.25mm-thick layer). A web-based validated program (Research Randomizer) generated a randomized list to define the treatment sides. The randomization results were kept blinded from the investigators who conducted the follow-up visits, from the pathologist, and the patients. Pre-treatment procedures include application of sunscreen for 15 minutes and curettage of the treatment area. Illumination is performed using 2 hours daylight-exposure. Efficacy is assessed clinically, and histologically at 3 and 12 months by blinded observers. Pain during and after treatments and adverse reactions at one week are recorded.

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

Daylight-mediated Photodynamic Therapy of Actinic Keratoses: a Randomized, Double-blinded Pilot Study Comparing Topical 0.2% Hexylaminolaevulinate With 16% Methylaminolaevulinate

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)

Clinical lesion clearance is observed by a blinded observer

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.

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.

Helsinki University Central Hospital

Joint Authority for Päijät-Häme Social and Health Care

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)

Hexylaminolaevulinate Cream

16% methylaminolaevulinate (Metvix, Galderma)

Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT

Methylaminolaevulinate Cream

0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and 16% methylaminolaevulinate (Metvix, Galderma) in a split-face design

Hexylaminolaevulinate and Methylaminoalevulinate Cream

Age, Categorical

Age, Continuous

Sex: Female, Male

Finland

Region of Enrollment

As the study was conducted as a single center pilot study, the results should be confirmed in a larger trial also valuing the patient complete response rates. A further limitation was we did not record light-doses.

Md, PhD Noora Neittaanmäki-Perttu

0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral)

Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream

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

Histological Lesion Clearance

Clinical Lesion Clearance

Adverse Reactions

Pain Assesment (Visual Analog Scale)

Clearance of Field Cancerization in Hyperspectral Images

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

Spots Global Cancer Trial Database for hal

Every month we try and update this database with for hal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hal

Every month we try and update this database with for hal cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hal cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.