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| Name | Class |
|---|---|
| Helsinki University Central Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAL cream and MAL cream | Experimental | 0.2% HAL (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and MAL (Metvix, Galderma) used in a randomized split-face design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hexylaminolaevulinate cream | Drug | 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Histological Lesion Clearance | 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) | Baseline, 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Lesion Clearance | Clinical lesion clearance is observed by a blinded observer | Baseline, 3 months |
| Adverse Reactions | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance of Field Cancerization in Hyperspectral Images | Data not collected | 3 months |
Inclusion Criteria:
-Symmetrical actinic damage on face or scalp
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noora E Neittaanmäki-Perttu, MD | Päijät-Häme Cnetral Hospital, Helsinki University Central Hospital | Principal Investigator |
| Mari Grönroos, MD, PhD | Päijät Häme Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Päijät-Häme Central Hospital | Lahti | Lahti | 15850 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26011755 | Result | Neittaanmaki-Perttu N, Gronroos M, Karppinen TT, Tani TT, Snellman E. Hexyl-5-aminolaevulinate 0.2% vs. methyl-5-aminolaevulinate 16% daylight photodynamic therapy for treatment of actinic keratoses: results of a randomized double-blinded pilot trial. Br J Dermatol. 2016 Feb;174(2):427-9. doi: 10.1111/bjd.13924. Epub 2015 Nov 20. No abstract available. |
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International peer-reviewed publication
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hexylaminolaevulinate and Methylaminoalevulinate Cream | 0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and 16% methylaminolaevulinate (Metvix, Galderma) in a split-face design |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Histological Lesion Clearance | 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) | One patient was excluded from the histological analysis because one biopsied lesion clinically taken as an AK appeared histologically to be seborrheic eczema. | Posted | Mean | Full Range | percentage of complete histological clea | Baseline, 3 months | Punch biopsies | Participants |
|
Adverse reactions were assessed by blinded observer at one week after treatment Cosmetic outcome was evaluated at 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hexylaminolaevulinate Cream | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness, crusting, scaling; minimal | Skin and subcutaneous tissue disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Md, PhD Noora Neittaanmäki-Perttu | Helsinki university central hospital | +358407190362 | noora.neittaanmaki@fimnet.fi |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C419924 | 5-aminolevulinic acid hexyl ester |
| C475457 | methyl 5-aminolevulinate |
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| Methylaminolaevulinate cream | Drug | MAL 16% is used as photosensitizer for daylight-PDT |
|
|
| One week |
| Pain Assesment (Visual Analog Scale) | 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. | 12 hours |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Methylaminolaevulinate Cream | 16% methylaminolaevulinate (Metvix, Galderma) Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT |
|
|
| Secondary | Clinical Lesion Clearance | Clinical lesion clearance is observed by a blinded observer | Posted | Mean | Full Range | percentage of lesions in complete respon | Baseline, 3 months | AK lesions | Participants |
|
|
|
| Secondary | Adverse Reactions | 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. | Posted | Number | participants | One week |
|
|
|
| Secondary | Pain Assesment (Visual Analog Scale) | 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. | Posted | Mean | Full Range | Mean maximal pain VAS score | 12 hours |
|
|
|
| Other Pre-specified | Clearance of Field Cancerization in Hyperspectral Images | Data not collected | Not Posted | 3 months |
| 0 |
| 14 |
| 14 |
| 14 |
| EG001 | Methylaminolaevulinate Cream | 16% methylaminolaevulinate (Metvix, Galderma) Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT | 0 | 14 | 14 | 14 |
| Redness, scaling, crusting; Mild | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Redness, crusting, scaling; intermediate | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Redness, scaling, crusting; Severe | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |