Keratosis, Actinic
Conditions
Brief summary
The primary purpose for this study is to assess recurrence of Actinic Keratosis in participants achieving complete response treated in earlier study.
Detailed description
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).
Interventions
DRUGMAL Cream
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.
DRUGVehicle cream
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.
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants who have completed earlier study RD.06.SPR.112199 (NCT04085367) and achieved complete response at last visit * Participants fully understand and sign an informed consent form (ICF) before any study procedure begins * Participants willing and able to perform all study protocol requirements
Exclusion criteria
* Participants developing or experiencing any condition that may not be safe for them or not compliant will be excluded * Pertinent not compliant with study conditions or PI instructions during the earlier study - Lumexia Ph 3
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54 | 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. |
| Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28 | 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. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 87 |
| 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. | 38 |
| Total | 125 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Study terminated by Sponsor | 13 | 10 |
Baseline characteristics
| Characteristic | Vehicle Cream Arm | Total | MAL Cream Arm |
|---|---|---|---|
| Age, Continuous | 66.8 years STANDARD_DEVIATION 8.89 | 68.5 years STANDARD_DEVIATION 8.92 | 69.2 years STANDARD_DEVIATION 8.88 |
| Fitzpatrick Skin Type Type I | 1 Participants | 7 Participants | 6 Participants |
| Fitzpatrick Skin Type Type II | 16 Participants | 59 Participants | 43 Participants |
| Fitzpatrick Skin Type Type III | 19 Participants | 54 Participants | 35 Participants |
| Fitzpatrick Skin Type Type IV | 2 Participants | 5 Participants | 3 Participants |
| Fitzpatrick Skin Type Type V | 0 Participants | 0 Participants | 0 Participants |
| Fitzpatrick Skin Type Type VI | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 38 Participants | 125 Participants | 87 Participants |
| Sex: Female, Male Female | 25 Participants | 54 Participants | 29 Participants |
| Sex: Female, Male Male | 13 Participants | 71 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 87 | 0 / 38 |
| other Total, other adverse events | 22 / 87 | 11 / 38 |
| serious Total, serious adverse events | 0 / 87 | 0 / 38 |
Outcome results
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.
Time frame: At Week 54
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAL Cream Arm | Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54 | 30 Participants |
| Vehicle Cream Arm | Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54 | 12 Participants |
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.
Time frame: At Week 28
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAL Cream Arm | Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28 | 19 Participants |
| Vehicle Cream Arm | Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28 | 8 Participants |
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.
Time frame: At Week 28 and Week 54
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MAL Cream Arm | Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54 | At Week 28 | 6.91 Percent recurrence | Standard Deviation 14.875 |
| MAL Cream Arm | Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54 | At Week 54 | 10.46 Percent recurrence | Standard Deviation 15.692 |
| Vehicle Cream Arm | Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54 | At Week 28 | 7.50 Percent recurrence | Standard Deviation 16.154 |
| Vehicle Cream Arm | Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54 | At Week 54 | 12.72 Percent recurrence | Standard Deviation 20.669 |