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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
125
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.
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.
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
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
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Galderma Investigational Site (Site#8447)
Fort Smith, Arkansas, United States
Galderma Investigational Site (Site#8577)
Encinitas, California, United States
Galderma Investigational Site (Site#8636)
Fountain Valley, California, United States
Galderma Investigational Site (Site#8224)
Fremont, California, United States
Galderma Investigational Site (Site#8778)
Denver, Colorado, United States
Galderma Investigational Site (Site#8440)
Greenwood Village, Colorado, United States
Galderma Investigational Site (Site#8479)
Bradenton, Florida, United States
Galderma Investigational Site (Site#8769)
Lake Worth, Florida, United States
Galderma Investigational Site (8770)
Lehigh Acres, Florida, United States
Galderma Investigational Site (Site#8765)
North Miami Beach, Florida, United States
...and 43 more locations