Pretreatment with ablative fractional laser and microdermabrasion before photodynamic therapy for solar keratoses in chronically sun-damaged skin

Pretreatment with ablative fractional laser and microdermabrasion before photodynamic therapy for actinic keratoses in field-cancerized skin

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002331-18-DK

Enrollment

Unknown

Registered

2015-06-25

Start date

2016-05-25

Completion date

Unknown

Last updated

2017-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients over 18 years of age two similar areas with actinic keratoses and field-cancerized skin of each at least 50 cm2 MedDRA version: 19.0 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Trade Name: Metvix creme 160 mg/g Pharmaceutical Form: Cream INN or Proposed INN: methyl aminolevulinate hydrochloride Other descriptive name: METHYL AMINOLEVULINATE HYDROCHLORIDE Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients over 18 years old with two similar skin areas of each 50 cm2, 5 actinic keratosis, and field-cancerization Fertile women with negative pregnancy test and using safe contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: porphyria allergy to Metvix creme infiltrating tumours in treatment area Photodynamic therapy or laser therapy within 1 months of treatment area pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Main Objective: Comparison of treatment efficacy of pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic with methyl aminolevulinate for actinic keratoses;Secondary Objective: Local skin reactions following pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic with methyl aminolevulinate for actinic keratoses;Primary end point(s): Treatment efficacy assessed as lesion complete response rate, defined as as number of actinic keratosis at 12 weeks post-treatment compared to baseline in each patient ;Timepoint(s) of evaluation of this end point: 12 weeks after treatment	—

Measure

Time frame

Main Objective: Comparison of treatment efficacy of pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic with methyl aminolevulinate for actinic keratoses;Secondary Objective: Local skin reactions following pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic with methyl aminolevulinate for actinic keratoses;Primary end point(s): Treatment efficacy assessed as lesion complete response rate, defined as as number of actinic keratosis at 12 weeks post-treatment compared to baseline in each patient ;Timepoint(s) of evaluation of this end point: 12 weeks after treatment

—

Secondary

Measure	Time frame
Secondary end point(s): local skin reactions after treatment evaluated as acute reactions: erythema, oedema, crusting, scaling, pustules and late reactions: hypopigmentation, hyperpigmentation or scars New actinic keratoses in treatment area compared to baseline Pain during laser treatment and daylight exposure Cosmetic outcome assessed by patient and investigator Photorejuvenation from baseline photos evaluated by investigator;Timepoint(s) of evaluation of this end point: acute skin reactions: day 1-5 after treatment pain: during treatment cosmetic outcome, photorejuvenation and late skin reactions: 12 weeks after treatment	—

Measure

Time frame

Secondary end point(s): local skin reactions after treatment evaluated as acute reactions: erythema, oedema, crusting, scaling, pustules and late reactions: hypopigmentation, hyperpigmentation or scars New actinic keratoses in treatment area compared to baseline Pain during laser treatment and daylight exposure Cosmetic outcome assessed by patient and investigator Photorejuvenation from baseline photos evaluated by investigator;Timepoint(s) of evaluation of this end point: acute skin reactions: day 1-5 after treatment pain: during treatment cosmetic outcome, photorejuvenation and late skin reactions: 12 weeks after treatment

—

Countries

Denmark

Contacts

Public ContactKatrine Togsverd-Bo

Bispebjerg Hospital, Department of dermatology

katrinetogsverd@hotmail.com004553539178

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026