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A Randomized, Double-Blind, Vehicle-Controlled, Multicenter Study to Assess the Efficacy and Safety of Methyl aminolevulinate hydrochloride (MAL) 16.8% cream (CD06809-41) versus vehicle cream in the treatment of thin and moderately thick, non-hyperkeratotic, non-pigmented actinic keratosis of the face and scalp when using daylight photodynamic therapy (DL-PDT).
This was a randomized, double-blind, vehicle-controlled, multicenter, parallel-group study in adult participants with clinically-confirmed mild to moderate AKs on the face and the balding scalp, to be conducted at approximately 60 clinical sites in the United States. Sites were selected to ensure that diverse daylight conditions represented in the study to understand the effects of latitude, elevation, and climate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAL 16.8% Cream | Experimental | Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy [DL-PDT]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser. |
|
| MAL Vehicle Cream | Placebo Comparator | Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAL 16.8% cream | Drug | Day light photodynamic therapy with MAL 16.8% cream |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete Response at Week 12 | Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT). | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Lesion Complete Response at Week 12 | Lesion complete response was defined as percent reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment. This outcome measure was analyzed as an intra-individual comparison between MAL cream and Vehicle cream. | Baseline, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site (Site 8768) | Tucson | Arizona | 85718 | United States | ||
| Galderma Investigational Site (Site 8447) |
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A total of 557 participants were randomized in 2:1 ratio in two treatment group, MAL 16.8% cream and vehicle cream in study centers in the United States with diverse latitude, altitude, and climate characteristics.
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| ID | Title | Description |
|---|---|---|
| FG000 | MAL 16.8% Cream | Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy [DL-PDT]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2020 | Mar 1, 2022 |
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| MAL Vehicle Cream | Drug | Day light photodynamic therapy with MAL vehicle cream |
|
| Percentage of Participants With Partial Response at Week 12 | Participants achieving partial response was defined as participants with 75% or greater reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment, comparing MAL cream with vehicle cream. | Week 12 |
| Fort Smith |
| Arkansas |
| 72916-6103 |
| United States |
| Galderma Investigational Site (Site 8577) | Encinitas | California | 92024 | United States |
| Galderma Investigational Site (Site 8636) | Fountain Valley | California | 92708 | United States |
| Galderma Investigational Site (Site 8224) | Fremont | California | 94538 | United States |
| Galderma Investigational Site (Site 8114) | Fresno | California | 93720 | United States |
| Galderma Investigational Site (Site 8758) | San Diego | California | 92121 | United States |
| Galderma Investigational Site (Site 8608) | Santa Monica | California | 90404 | United States |
| Galderma Investigational Site (Site 8778) | Denver | Colorado | 80210 | United States |
| Galderma Investigational Site (Site 8440) | Greenwood Village | Colorado | 80111 | United States |
| Galderma Investigational Site (Site 8479) | Bradenton | Florida | 34209 | United States |
| Galderma Investigational Site (Site 8770) | Lehigh Acres | Florida | 33936 | United States |
| Galderma Investigational Site (Site 8656) | Miami | Florida | 33137 | United States |
| Galderma Investigational Site (Site 8765) | North Miami Beach | Florida | 33162 | United States |
| Galderma Investigation Site (Site 8769) | Palm Springs | Florida | 33461 | United States |
| Galderma Investigational Site (Site 8734) | Pembroke Pines | Florida | 33028 | United States |
| Galderma Investigational Site (Site 8529) | Sanford | Florida | 32771 | United States |
| Galderma Investigational Site (Site 8126) | West Palm Beach | Florida | 33401 | United States |
| Galderma Investigational Site (Site 8683) | Atlanta | Georgia | 30342-1418 | United States |
| Galderma Investigational Site (Site 8860) | Atlanta | Georgia | 30342 | United States |
| Galderma Investigational Site (Site 8667) | Columbus | Georgia | 31904 | United States |
| Galderma Investigational Site (Site 8755) | Boise | Idaho | 83704 | United States |
| Galderma Investigational Site (Site 8838) | Darien | Illinois | 60561 | United States |
| Galderma Investigational Site (Site 8724) | Louisville | Kentucky | 40241 | United States |
| Galderma Investigational Site (Site 8208) | Beverly | Massachusetts | 01915 | United States |
| Galderma Investigational Site (Site 8574) | Clarkston | Michigan | 48346-3198 | United States |
| Galderma Investigation Site (Site 8757) | Saint Joseph | Michigan | 49085 | United States |
| Galderma Investigational Site (Site 8762) | Edina | Minnesota | 55424-1200 | United States |
| Galderma Investigational Site (Site 8140) | New Brighton | Minnesota | 55112 | United States |
| Galderma Investigational Site (Site 8219) | St Louis | Missouri | 63141 | United States |
| Galderma Investigational Site (Site 8869) | St Louis | Missouri | 63141 | United States |
| Galderma Investigational Site (Site 8048) | Omaha | Nebraska | 68144 | United States |
| Galderma Investigational Site (Site 8420) | Portsmouth | New Hampshire | 03801 | United States |
| Galderma Investigational Site (Site 8759) | Albuquerque | New Mexico | 87102 | United States |
| Galderma Investigational Site (Site 8242) | Brooklyn | New York | 11203 | United States |
| Galderma Investigational Site (Site 8733) | New York | New York | 10022 | United States |
| Galderma Investigational Site (Site 8279) | New York | New York | 10075 | United States |
| Galderma Investigational Site (Site 8566) | Charlotte | North Carolina | 28277 | United States |
| Galderma Investigational Site (Site 8726) | Wilmington | North Carolina | 28405-3176 | United States |
| Galderma Investigational Site (Site 8595) | Dublin | Ohio | 43016 | United States |
| Galderma Investiational Site (Site 8212) | Portland | Oregon | 97210-2996 | United States |
| Galderma Investigational Site (Site 8255) | Philadelphia | Pennsylvania | 19103 | United States |
| Galderma Investigational Site (Site 8721) | Pittsburgh | Pennsylvania | 15213 | United States |
| Galderma Investigational Site (Site 8754) | Sugarloaf | Pennsylvania | 18249 | United States |
| Galderma Investigational Site (Site 8777) | Charleston | South Carolina | 29407 | United States |
| Galderma Investigational Site (Site 8207) | Nashville | Tennessee | 37215 | United States |
| Galderma Investigational Site (Site 8076) | Austin | Texas | 78759 | United States |
| Galderma Investigational Site (Site 8139) | College Station | Texas | 77845 | United States |
| Galderma Investigational Site (Site 8664) | Frisco | Texas | 75034 | United States |
| Galderma Investigational Site (Site # 8576) | Houston | Texas | 77056 | United States |
| Galderma Investigational Site (Site 8546) | Pflugerville | Texas | 78660-3519 | United States |
| Galderma Investigational Site (Site 8672) | Salt Lake City | Utah | 84117 | United States |
| Galderma Investigational Site (Site 8776) | St. George | Utah | 84790 | United States |
| Galderma Investigational Site (Site 8761) | West Jordan | Utah | 84101 | United States |
| Galderma Investigational Site (Site 8057) | Lynchburg | Virginia | 24501 | United States |
| Galderma Investigational Site (Site 8779) | Burien | Washington | 98168 | United States |
| Galderma Investigational Site (Site 8039) | Spokane | Washington | 99202 | United States |
| Galderma Investigational Site (Site 8760) | Spokane | Washington | 99202 | United States |
| Galderma Investigational Site (Site 8725) | Morgantown | West Virginia | 26505 | United States |
| Galderma Investigational Site (Site 8231) | Aibonito | 00705 | Puerto Rico |
| FG001 | MAL Vehicle Cream | Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser. |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat (ITT) analysis population included all participants randomized in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | MAL 16.8% Cream | Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (Daylight photodynamic therapy [DL-PDT]). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser. |
| BG001 | MAL Vehicle Cream | Participants received two treatment session at least 2 weeks apart. Investigator applied a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants went outside in daylight for 2 hours (DL-PDT). After this time, the cream was removed by investigative site personnel by washing the skin with gentle skin cleanser. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Percentage of Participants With Complete Response at Week 12 | Complete response was defined as clearance of all AK lesion treated, at week 12 after the last Daylight photodynamic therapy (DL-PDT). | ITT analysis population included all participants randomized in the study. | Posted | Number | percentage of participants | Week 12 |
|
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| |||||||||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Lesion Complete Response at Week 12 | Lesion complete response was defined as percent reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment. This outcome measure was analyzed as an intra-individual comparison between MAL cream and Vehicle cream. | ITT analysis population included all participants randomized in the study. | Posted | Mean | Standard Error | percent change | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Partial Response at Week 12 | Participants achieving partial response was defined as participants with 75% or greater reduction from baseline in the number of cleared treated lesions, at 12 weeks after the last DL-PDT treatment, comparing MAL cream with vehicle cream. | ITT analysis population included all participants randomized in the study. | Posted | Number | percentage of participants | Week 12 |
|
Baseline up to Week 14
Safety population consisted of all randomized participants who received at least 1 application of study drug.
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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 | MAL 16.8% Cream | Participants received two treatment session at least 2 weeks apart. Investigator was to apply a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants were to go outside in daylight for 2 hours. After this time, the cream was to be removed by investigative site personnel by washing the skin with gentle skin cleanser. | 0 | 364 | 5 | 364 | 89 | 364 |
| EG001 | MAL Vehicle Cream | Participants received two treatment session at least 2 weeks apart. Investigator was to apply a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants were to go outside in daylight for 2 hours. After this time, the cream was to be removed by investigative site personnel by washing the skin with gentle skin cleanser. | 0 | 193 | 1 | 193 | 41 | 193 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back injury | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Streptococcal endocarditis | Infections and infestations | MedDRA (22.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Application site pain | General disorders | MedDRA (22.0) | Non-systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Application site dermatitis | General disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Application site pruritus | General disorders | MedDRA (22.0) | Non-systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (22.0) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | +1 | Clinical.Studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2021 | Mar 1, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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