Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Methyl 5-aminolevulinate

WIthin each participant, two 50 cm2 adjacent test areas were randomized to laser or microdermabrasion pretreatment prior to daylight photodynamic therapy.

One 50 cm2 test area was randomized to pretreatment using a fractional 2940 nm Er:YAG laser (Joule®; Sciton Inc., Palo Alto, CA, USA). To remove hyperkeratosis, a fully-ablative 4 mm handpiece was optionally applied, followed by a single pass of a fractional Profrax 430 handpiece for all AKs. Subsequent field treatment consisted of a single pass of the Profrax 430 handpiece over the entire test area. Immediately after pretreatment, a 0.5 mm layer of methyl aminolevulinate (Metvix ® cream 16%; Galderma, Paris, France) was applied. After 30 minutes, patients were exposed to 2 hours of ambient daylight, according to approved procedure. After light exposure, cream was wiped off and test areas were covered for the remainder of the day.

Ablative Fractional Carbon Dioxide (CO2) Laser

Another adjacent 50 cm2 test area was exposed to microdermabrasion using an MD pad with 58.5 µm-diameter particles (Ambu® Skin Prep Pads 2121M; Ambu A/S, Ballerup, Denmark). Lesion-directed treatment consisted of an increasing number of swipes concentrated to AK lesions. During field treatment, multiple swipes were applied in perpendicular directions over the entire test area. Immediately after pretreatment, a 0.5 mm layer of methyl aminolevulinate (Metvix ® cream 16%; Galderma, Paris, France) was applied. After 30 minutes, patients were exposed to 2 hours of ambient daylight, according to approved procedure. After light exposure, cream was wiped off and test areas were covered for the remainder of the day.

Microdermabrasion

Merete Haedersdal, MD, Dr. Med

Comparison of treatment efficacy and safety of pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic therapy with methyl aminolevulinate for actinic keratoses

For each study participant, two test areas (A and B) are demarcated in the same anatomical region, with each area containing no less than 5 actinic keratoses (AKs). Test areas are randomized to receive skin pretreatment of EITHER ablative fractional laser OR microdermabrasion prior to photodynamic therapy using methyl aminolevulinate.

Efficacy, local skin reactions and safety of both test areas are evaluated over a 12-15 week follow up period.

Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin

Pretreatment With Ablative Fractional Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin

Percentage clearance of baseline actinic keratoses (AKs), determined by the ratio of AK lesions that are clinically resolved 12-15 weeks after treatment compared to the AK number at baseline.

Number of new actinic keratoses (AKs) identified clinically 12-15 weeks after treatment and that were not present at the baseline evaluation.

Local skin reactions scale (min:0; better and max: 3; worse) used to grade each of the following parameters: erythema, edema, crusting, pustules, ulceration and scabbing, scaling.

The severity of each evaluated clinically on a 4-point scale where 0 = none, 1= mild, 2= moderate and 3= severe.

With 7 parameters the sum of all scores will produce a maximum composite score of 21.

Sun damage is evaluated clinically on a 4 point scale where 0 = none, 1= mild, 2= moderate and 3= severe sun damage.

Patient-reported pain during treatments is evaluated using the visual analog scale (VAS) where 0= no pain and 10= worst imaginable pain.

Side effects are evaluated over the course 12-15 weeks following treatment. In addition to unforeseen adverse events, specific side effects including the clinical presence of infection, scarring, hypopigmentation and hyperpigmentation are recorded.

Cosmetic appearance of treated areas is evaluated by investigators clinically (scores on a scale) using a 4-point scale where 0 = none, 1= acceptable, 2= good and 3= excellent outcome.

Cosmetic appearance is evaluated by patients at the end of the study (scores on a scale) using a 4 point scale where 0 = none, 1= acceptable, 2= good and 3= excellent

Patients were asked to report which pretreatment they preferred: Laser, microdermabrasion, or no preference

Galderma R&D

Bispebjerg Hospital

Professor and Senior Physician

Intra-individual design of 18 participants. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant is allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy. Thus, each participants receives both inventions (18 test areas received AFL and 18 test areas received MD).

Split-Person: Ablative Fractional Carbon Dioxide Laser or Microdermabrasion

Two 50 cm2 test areas (Test Area A and B) are demarcated on the skin of each study participant. One test area is randomized to receive the intervention: Ablative Fractional Carbon Dioxide (CO2) Laser prior to standard daylight photodynamic therapy. The other test area is randomized to receive the intervention: microdermabrasion prior to standard daylight photodynamic therapy.

Ablative Fractional Carbon Dioxide (CO2) Laser: Ablative Fractional Carbon Dioxide (CO2) Laser treatment is randomly allocated to one of two tests areas in each study participant. Laser treatment consists of targeted ablation of actinic keratoses and field laser treatment of the entire test area. After laser treatment, application of methyl aminolevulinate (MAL), a topical photosensitising agent, is performed. The test area thereafter undergoes 2 hours of daylight photodynamic therapy.

Microdermabrasion: Microdermabrasion (processing of the skin with a sandpaper-like material) is randomly allocated to one of two tests areas in each study participant. Microdermabrasion treatment consists of targeted treatment of actinic keratoses and field treatment of the entire test area. Afterwards, application of methyl aminolevulinate (MAL), a topical photosensitising agent, is performed. The test area then undergoes 2 hours of daylight photodynamic therapy.

Split Person Design: Pretreatment With Ablative Fractional Carbon Dioxide Laser or Microdermabrasion

Age, Categorical

Age, Continuous

Sex: Female, Male

Denmark

Region of Enrollment

Each participant had two skin areas that individually were randomized to receive either microdermabrasion or ablative fractional laser prior to photodynamic therapy. Thus, with 18 participants, we had 36 test areas.

Emily Wenande

Ablative Fractional Laser

Intra-individual design of 18 participants. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant is allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy. Thus, each participants received both inventions (18 test areas received AFL and 18 test areas received MD).

Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion

Percentage AK clearance in test areas receiving either AFL (18) or microdermabrasion (18) assisted daylight PDT treatment

Complete Clearance (%) of Actinic Keratoses (AKs)

New Actinic Keratoses (AKs)

Ablative Frational Laser

Two 50 cm2 test areas (Test Area A and B) are demarcated on the skin of each study participant. One test area is randomized to receive the intervention: Ablative Fractional Carbon Dioxide (CO2) Laser prior to standard daylight photodynamic therapy. The other test area is randomized to receive the intervention: microdermabrasion prior to standard daylight photodynamic therapy.

Ablative Fractional Carbon Dioxide (CO2) Laser: Ablative Fractional Carbon Dioxide (CO2) Laser treatment is randomly allocated to one of two tests areas in each study participant. Laser treatment consists of targeted ablation of actinic keratoses and field laser treatment of the entire test area. After laser treatment, application of methyl aminolevulinate (MAL), a topical photosensitizing agent, is performed. The test area thereafter undergoes 2 hours of daylight photodynamic therapy.

Pretreatment

Severity of Local Skin Reactions (LSRs)

Degree of Sun Damage

Treatment-related Pain

Treatment-related Side Effects

Investigator-reported Cosmesis (Clinical Evaluation)

Patient-reported Cosmesis

No Preference

Patient Pretreatment Preference

Intra-individual design. "All study participants" are grouped into a single arm. Two adjacent skin areas (test areas) on each participant was allocated through randomization to two different interventions: 1) Pretreatment with Ablative Fractional (AFL) CO2 laser OR 2) Microdermabrasion (MD) prior to standard daylight photodynamic therapy.

Description of intervention: Ablative Fractional CO2 laser: CO2 laser treatment is randomly allocated to one of two tests areas within each study participant. Laser treatment consists of targeted ablation of actinic keratoses and field laser treatment of the entire test area. After laser treatment, application of methyl aminolevulinate (MAL), a topical photosensitizing agent, is performed. The test area thereafter undergoes 2 hours of daylight photodynamic therapy.

Microdermabrasion: Microdermabrasion (processing of the skin with a sandpaper-like material) is randomly allocated to one of two tests areas in each study participant. Microdermabrasion treatment consists of targeted treatment of actinic keratoses and field treatment of the entire test area. Afterwards, application of methyl aminolevulinate (MAL), a topical photosensitizing agent, is performed. The test area then undergoes 2 hours of daylight photodynamic therapy.

Spots Global Cancer Trial Database for Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin

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