Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002331-18 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion | Experimental | WIthin each participant, two 50 cm2 adjacent test areas were randomized to laser or microdermabrasion pretreatment prior to daylight photodynamic therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ablative Fractional Carbon Dioxide (CO2) Laser | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Clearance (%) of Actinic Keratoses (AKs) | 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. | 12-15 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| New Actinic Keratoses (AKs) | Number of new actinic keratoses (AKs) identified clinically 12-15 weeks after treatment and that were not present at the baseline evaluation. | 12-15 weeks post-treatment |
| Severity of Local Skin Reactions (LSRs) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Merete Haedersdal, MD, Dr. Med | Bispebjerg Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
| ID | Title | Description |
|---|---|---|
| BG000 | Split Person Design: Pretreatment With 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. |
| 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 | Complete Clearance (%) of Actinic Keratoses (AKs) | 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. | Percentage AK clearance in test areas receiving either AFL (18) or microdermabrasion (18) assisted daylight PDT treatment | Posted | Mean | Full Range | percentage (%) of AK clearance | 12-15 weeks post-treatment | Test areas | Test areas |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Split-Person: Ablative Fractional Carbon Dioxide Laser or Microdermabrasion | 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). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection in test areas treated with AFL | Infections and infestations | Systematic Assessment | Staph aureus infection was noted in 3/18 test areas pretreated with ablative fractional laser |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Wenande | Bispebjerg Hospital | +4540505590 | emilycathrinew@hotmail.com |
Not provided
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Microdermabrasion | Device | 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. |
|
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.
| Day 3-6 post treatment |
| Degree of Sun Damage | Sun damage is evaluated clinically on a 4 point scale where 0 = none, 1= mild, 2= moderate and 3= severe sun damage. | 12-15 weeks post-treatment |
| Treatment-related Pain | Patient-reported pain during treatments is evaluated using the visual analog scale (VAS) where 0= no pain and 10= worst imaginable pain. | during treatment (day 0) |
| Treatment-related Side Effects | 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. | up to 12-15 weeks post-treatment |
| Investigator-reported Cosmesis (Clinical Evaluation) | 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. | 12-15 weeks post-treatment |
| Patient-reported Cosmesis | 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 | 12-15 weeks post-treatment |
| Patient Pretreatment Preference | Patients were asked to report which pretreatment they preferred: Laser, microdermabrasion, or no preference | 12-15 weeks post-treatment |
| Skin areas |
|
| Participants |
| Participants |
|
| Age, Continuous | Mean | Full Range | years | Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
|
|
| Secondary | New Actinic Keratoses (AKs) | Number of new actinic keratoses (AKs) identified clinically 12-15 weeks after treatment and that were not present at the baseline evaluation. | Posted | Median | Inter-Quartile Range | New AK lesions | 12-15 weeks post-treatment | Test areas | Test areas |
|
|
|
| Secondary | Severity of Local Skin Reactions (LSRs) | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Day 3-6 post treatment | Test areas | Test areas |
|
|
|
| Secondary | Degree of Sun Damage | Sun damage is evaluated clinically on a 4 point scale where 0 = none, 1= mild, 2= moderate and 3= severe sun damage. | Posted | Median | Inter-Quartile Range | score on a scale | 12-15 weeks post-treatment | Skin Areas | Skin Areas |
|
|
|
| Secondary | Treatment-related Pain | Patient-reported pain during treatments is evaluated using the visual analog scale (VAS) where 0= no pain and 10= worst imaginable pain. | Posted | Median | Inter-Quartile Range | units on a scale | during treatment (day 0) |
|
|
|
| Secondary | Treatment-related Side Effects | 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. | Posted | Number | Local Staf infection | up to 12-15 weeks post-treatment | Test areas | Test areas |
|
|
|
| Secondary | Investigator-reported Cosmesis (Clinical Evaluation) | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 12-15 weeks post-treatment | Test areas | Test areas |
|
|
|
| Secondary | Patient-reported Cosmesis | 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 | Posted | Median | Inter-Quartile Range | score on a scale | 12-15 weeks post-treatment | Test areas | Test areas |
|
|
|
| Secondary | Patient Pretreatment Preference | Patients were asked to report which pretreatment they preferred: Laser, microdermabrasion, or no preference | Posted | Count of Participants | Participants | 12-15 weeks post-treatment |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 3 |
| 18 |
|
| Infection in test areas treated with MD | Infections and infestations | Systematic Assessment | Staph aureus infection was noted in 1/18 test areas pretreated with microdermabrasion |
|
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|