Trial Outcomes & Findings for A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study (NCT NCT04269395)

Last Updated: 2023-10-10

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

125 participants

Primary outcome timeframe

At Week 54

Results posted on

2023-10-10

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	87	38
Overall Study COMPLETED	73	28
Overall Study NOT COMPLETED	14	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Lost to Follow-up	1	0
Overall Study Study terminated by Sponsor	13	10

Baseline Characteristics

A Study to Assess Recurrence of Actinic Keratosis in Participants Treated With Methyl Aminolevulinate Hydrochloride Cream or Vehicle Cream Who Achieved Complete Response to Treated Lesions in Earlier Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MAL Cream Arm n=87 Participants 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.	Vehicle Cream Arm n=38 Participants 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.	Total n=125 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 8.88 • n=99 Participants	66.8 years STANDARD_DEVIATION 8.89 • n=107 Participants	68.5 years STANDARD_DEVIATION 8.92 • n=206 Participants
Sex: Female, Male Female	29 Participants n=99 Participants	25 Participants n=107 Participants	54 Participants n=206 Participants
Sex: Female, Male Male	58 Participants n=99 Participants	13 Participants n=107 Participants	71 Participants n=206 Participants
Race/Ethnicity, Customized White	87 Participants n=99 Participants	38 Participants n=107 Participants	125 Participants n=206 Participants
Fitzpatrick Skin Type Type I	6 Participants n=99 Participants	1 Participants n=107 Participants	7 Participants n=206 Participants
Fitzpatrick Skin Type Type II	43 Participants n=99 Participants	16 Participants n=107 Participants	59 Participants n=206 Participants
Fitzpatrick Skin Type Type III	35 Participants n=99 Participants	19 Participants n=107 Participants	54 Participants n=206 Participants
Fitzpatrick Skin Type Type IV	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Fitzpatrick Skin Type Type V	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Fitzpatrick Skin Type Type VI	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MAL Cream Arm n=75 Participants 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.	Vehicle Cream Arm n=30 Participants 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.
Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 54	30 Participants	12 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	MAL Cream Arm n=81 Participants 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.	Vehicle Cream Arm n=38 Participants 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.
Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54 At Week 28	6.91 Percent recurrence Standard Deviation 14.875	7.50 Percent recurrence Standard Deviation 16.154
Percent Recurrence of Cleared Treated AK Lesions at Week 28 and Week 54 At Week 54	10.46 Percent recurrence Standard Deviation 15.692	12.72 Percent recurrence Standard Deviation 20.669

SECONDARY outcome

Timeframe: At Week 28

Outcome measures

Outcome measures
Measure	MAL Cream Arm n=81 Participants 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.	Vehicle Cream Arm n=38 Participants 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.
Number of Participants With Recurrence of Any (>=1) Cleared Treated AK Lesions at Week 28	19 Participants	8 Participants

Adverse Events

MAL Cream Arm

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Vehicle Cream Arm

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical Operations

Galderma

Phone: 8179615000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	MAL Cream Arm n=87 participants at risk 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.	Vehicle Cream Arm n=38 participants at risk 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.
Skin and subcutaneous tissue disorders Actinic Keratosis	13.8% 12/87 • 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.	13.2% 5/38 • 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.
Skin and subcutaneous tissue disorders Androgenetic Alopecia	0.00% 0/87 • 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.	2.6% 1/38 • 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.
Skin and subcutaneous tissue disorders Erythema	1.1% 1/87 • 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.	0.00% 0/38 • 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.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/87 • 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.	2.6% 1/38 • 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.
General disorders Application site erythema	3.4% 3/87 • 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.	2.6% 1/38 • 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.
General disorders Application site atrophy	2.3% 2/87 • 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.	0.00% 0/38 • 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.
General disorders Gait disturbance	1.1% 1/87 • 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.	0.00% 0/38 • 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.
Infections and infestations Corona virus infection	3.4% 3/87 • 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.	2.6% 1/38 • 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.
Infections and infestations Sinusitis	1.1% 1/87 • 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.	2.6% 1/38 • 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.
Infections and infestations Herpes zoster	0.00% 0/87 • 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.	2.6% 1/38 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 1/87 • 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.	2.6% 1/38 • 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.
Musculoskeletal and connective tissue disorders Back pain	1.1% 1/87 • 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.	0.00% 0/38 • 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.
Musculoskeletal and connective tissue disorders Osteoporosis	1.1% 1/87 • 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.	0.00% 0/38 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	1.1% 1/87 • 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.	0.00% 0/38 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	1.1% 1/87 • 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.	0.00% 0/38 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/87 • 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.	2.6% 1/38 • 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.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/87 • 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.	2.6% 1/38 • 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.
Injury, poisoning and procedural complications Fall	0.00% 0/87 • 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.	2.6% 1/38 • 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.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/87 • 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.	2.6% 1/38 • 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.
Nervous system disorders Hypoaesthesia	1.1% 1/87 • 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.	0.00% 0/38 • 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.
Nervous system disorders Sciatica	0.00% 0/87 • 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.	2.6% 1/38 • 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.
Vascular disorders Hypertension	1.1% 1/87 • 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.	2.6% 1/38 • 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.
Gastrointestinal disorders Abdominal pain lower	1.1% 1/87 • 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.	0.00% 0/38 • 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.
Reproductive system and breast disorders Breast mass	0.00% 0/87 • 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.	2.6% 1/38 • 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.