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The study was terminated early as per Sponsor's decision
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The primary purpose for this study is to assess recurrence of Actinic Keratosis in participants achieving complete response treated in earlier study.
This is a double-blind, multicenter, long-term follow-up study. The primary purpose of this study is to assess recurrence of Actinic Keratosis in participants treated with Methyl aminolevulinate hydrochloride (MAL) 16.8 percent (%) cream (CD06809-41) or 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), for participants achieving complete response of treated lesions at Final Visit in Study RD.06.SPR.112199 (NCT04085367).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAL Cream Arm | Active Comparator | Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit of the active cream group, will continue for long-term follow-up to evaluate recurrence of AKs in this study. |
|
| Vehicle Cream Arm | Placebo Comparator | Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit in the vehicle cream group, will continue for long-term follow-up to evaluate recurrence of AKs in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAL Cream | Drug | No intervention will be administered as a part of this study. Participants who received MAL cream in RD.06.SPR.112199 study will be rolled over in the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54 | Participants with recurrence are defined as the participants with recurrence of any (greater than and equal to [>=] 1) cleared treated AK lesions. Number of participants with recurrence of any (>=1) cleared treated AK lesions at Week 54 was reported. | At Week 54 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54 | Recurrence is defined as the percentage of recurrence of cleared treated lesions. Percent recurrence of cleared treated actinic keratosis lesions at Week 28 and Week 54 was reported. | At Week 28 and Week 54 |
| Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Investigational Site (Site#8447) | Fort Smith | Arkansas | 72916 | United States | ||
| Galderma Investigational Site (Site#8577) |
125 participants (87 in Methyl aminolevulinate hydrochloride (MAL) 16.8% cream group and 38 in vehicle cream group) from main study RD.06.SPR.112199 were enrolled and treated in this study. Study was terminated early as in main study, primary analysis did not show superiority of MAL 16.8% cream with DL-PDT over vehicle cream with DL-PDT as of participant complete response (CR), and the sponsor decided not to apply for marketing authorization for the MAL 16.8% cream in combination with DL-PDT.
The study was conducted at 31 study centers in United States from 7 April 2020 to 1 September 2021. Participants who completed study RD.06.SPR.112199 (NCT04085367) and achieved complete response (CR) of all treated Actinic Keratosis (AKs) lesions at final visit of treatment, were continued to be followed in this for long-term follow-up (LTFU) study to assess recurrence.
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| ID | Title | Description |
|---|---|---|
| FG000 | MAL Cream Arm | Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit of the active cream group (MAL), continued for long-term follow-up to evaluate recurrence of AKs in this study. No treatment was given to participants in this study. |
| FG001 |
| 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 | Jan 15, 2021 | May 26, 2023 |
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|
| Vehicle cream | Drug | No intervention will be administered as a part of this study. Participants who received vehicle cream in RD.06.SPR.112199 study and achieved complete response, will be rolled over in the study. |
|
Participants with recurrence are defined as the participants with recurrence of any (greater than and equal to [>=] 1) cleared treated AK lesions. Number of participants with recurrence of any (>=1) cleared treated AK lesions at Week 28 was reported. |
| At Week 28 |
| 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#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#8769) | Lake Worth | Florida | 33461 | United States |
| Galderma Investigational Site (8770) | Lehigh Acres | Florida | 33936 | United States |
| Galderma Investigational Site (Site#8765) | North Miami Beach | Florida | 33162 | 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#8667) | Columbus | Georgia | 31904 | United States |
| Galderma Investigational Site (Site#8755) | Boise | Idaho | 83704 | United States |
| Galderma Investigational Site | Boise | Idaho | 83713 | 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 | United States |
| Galderma Investigational Site (Site#8757) | Saint Joseph | Michigan | 49085 | United States |
| Galderma Investigational Site | Edina | Minnesota | 55410 | United States |
| Galderma Investigational Site | St Louis | Missouri | 63141 | United States |
| Galderma Investigational Site (Site#8048) | Omaha | Nebraska | 68144 | United States |
| Galderma Investigational Site 9Site#8420) | Portsmouth | New Hampshire | 03801 | United States |
| Galderma Investigational Site (Site#8759) | Albuquerque | New Mexico | 87102 | United States |
| Galderma Investigational Site | Brooklyn | New York | 11209 | United States |
| Galderma Investigational Site | New York | New York | 10010 | United States |
| Galderma Investigational Site | New York | New York | 10022 | United States |
| Galderma Investigational Site | New York | New York | 10029-6501 | United States |
| Galderma Investigational Site | New York | New York | 10075 | United States |
| Galderma Investigational Site (Site#8566) | Charlotte | North Carolina | 28277 | United States |
| Galderma Investigational Site (Site#8595) | Dublin | Ohio | 43016 | United States |
| Galderma Investigational Site (Site#8212) | Portland | Oregon | 97210 | United States |
| Galderma Investigational Site | Philadelphia | Pennsylvania | 19103 | United States |
| Galderma Investigational Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Galderma Investigational Site | 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 | United States |
| Galderma Investigational Site (Site#8761) | Salt Lake City | Utah | 84101 | 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#8057) | Lynchburg | Virginia | 24501 | United States |
| Galderma Investigational Site (Site#8779) | Seattle | Washington | 98168 | United States |
| Galderma Investigational Site (Site#8760) | Spokane | Washington | 99202 | United States |
| Galderma Investigational Site 2(Site#8039) | 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 |
| Vehicle Cream Arm |
Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit in the vehicle cream group, continued for long-term follow-up to evaluate recurrence of AKs in this study. No treatment was given to participants in this study. |
| COMPLETED |
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| NOT COMPLETED |
|
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Safety population consisted of all enrolled participants and was to be used for all efficacy and safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | MAL Cream Arm | Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit of the active cream group (MAL), continued for long-term follow-up to evaluate recurrence of AKs in this study. No treatment was given to participants in this study. |
| BG001 | Vehicle Cream Arm | Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit in the vehicle cream group, continued for long-term follow-up to evaluate recurrence of AKs in this study. No treatment was given to participants in this study. |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Fitzpatrick Skin Type | Type I = White; very fair, red or blonde hair blue eyes; freckles; Always burns, never tans Type II = White, fair, red or blond hair; blue, hazel or green eyes; Usually burns, tans with difficulty Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily Type VI = Black; Never burns, tans very easily. | 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 | Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54 | Participants with recurrence are defined as the participants with recurrence of any (greater than and equal to [>=] 1) cleared treated AK lesions. Number of participants with recurrence of any (>=1) cleared treated AK lesions at Week 54 was reported. | Safety population consisted of all enrolled participants and was to be used for all efficacy and safety analyses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Week 54 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54 | Recurrence is defined as the percentage of recurrence of cleared treated lesions. Percent recurrence of cleared treated actinic keratosis lesions at Week 28 and Week 54 was reported. | Safety population consisted of all enrolled participants and was to be used for all efficacy and safety analyses. Screen failures were not to be included in the safety population. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "Number analyzed" signifies those participants who were evaluable at the specified timepoints. | Posted | Mean | Standard Deviation | Percent recurrence | At Week 28 and Week 54 |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28 | Participants with recurrence are defined as the participants with recurrence of any (greater than and equal to [>=] 1) cleared treated AK lesions. Number of participants with recurrence of any (>=1) cleared treated AK lesions at Week 28 was reported. | Safety population consisted of all enrolled participants and was to be used for all efficacy and safety analyses. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | At Week 28 |
|
From start of study drug administration up to Week 54
Safety population consisted of all enrolled participants and was to be used for all efficacy and safety analyses.
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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 Cream Arm | Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit of the active cream group (MAL), continued for long-term follow-up to evaluate recurrence of AKs in this study. No treatment was given to participants in this study. | 0 | 87 | 0 | 87 | 22 | 87 |
| EG001 | Vehicle Cream Arm | Participants who completed the study RD.06.SPR.112199 (NCT04085367) and achieved complete response of all treated lesions at the final visit in the vehicle cream group, continued for long-term follow-up to evaluate recurrence of AKs in this study. No treatment was given to participants in this study. | 0 | 38 | 0 | 38 | 11 | 38 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Actinic Keratosis | Skin and subcutaneous tissue disorders | 22.0 | Non-systematic Assessment |
| |
| Androgenetic Alopecia | Skin and subcutaneous tissue disorders | 22.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | 22.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | 22.0 | Non-systematic Assessment |
| |
| Application site erythema | General disorders | 22.0 | Non-systematic Assessment |
| |
| Application site atrophy | General disorders | 22.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | 22.0 | Non-systematic Assessment |
| |
| Corona virus infection | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 22.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 22.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 22.0 | Non-systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | 22.0 | Non-systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 22.0 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | 22.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | 22.0 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | 22.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | 22.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | 22.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | 22.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | 22.0 | Non-systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | 22.0 | Non-systematic Assessment |
|
This LTFU study was terminated early by the Sponsor because in the main study RD.06.SPR.112199, the primary analysis did not show superiority of MAL 16.8% cream with DL-PDT over vehicle cream with DL-PDT in terms of participant complete response (CR), and the sponsor decided not to apply for marketing authorization for the MAL 16.8% cream in combination with DL-PDT.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 8179615000 | 1 | Clinical.Studies@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2021 | May 26, 2023 | SAP_001.pdf |
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| 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 |
|
| Type II |
|
| Type III |
|
| Type IV |
|
| Type V |
|
| Type VI |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|