Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

List	Outcome	Time frame	Description
Primary	Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT)	12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT	All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation. Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed. The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated actinic keratosis (AK) lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed.
Primary	Overall Patient Complete Response 12 Weeks After the Last PDT (PP)	12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT	All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation. Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed. The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated AK lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed.
Secondary	Patient Histopathological Confirmed Response Rate	12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT	For the secondary confirmatory analysis, several superiority hypotheses were tested within a pre-defined hierarchic multiple testing procedure as described in the Statistical Analysis Protocoll (SAP). The key secondary efficacy variables were tested strictly in a pre-defined order to ensure the family-wise error rate (FWER) and the testing procedure had to be stopped once the first non-significant test was obtained. The results of the confirmatory analysis are presented in the order pre-defined by the confirmatory testing procedure. Assessments of the patient histopathological confirmed response (HCR) rates were based on the results from the biopsy taken 12 weeks after the last PDT from a representative AK lesion selected at screening. If the biopsy result for a patient revealed a residual AK, the patient was considered "not cleared" for the analysis irrespectively of the investigator's clinical assessment.
Secondary	Patient Complete Response 12 Weeks After PDT 1	12 weeks after PDT 1	The second key secondary efficacy variable in the hierarchic test procedure was the patient complete response (complete clearance of all treated AK lesions) assessed at 12 weeks after PDT 1.
Secondary	Lesion Complete Response 12 Weeks After Last PDT	12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT	The third key secondary efficacy variable in the hierarchic test procedure was the lesion complete response (completely cleared individual AK lesions) assessed at 12 weeks after last PDT.
Secondary	Patient Partial Response 12 Weeks After Last PDT	12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT	The fourth key secondary efficacy variable in the hierarchic test procedure was the patient partial response (defined as complete clearance of at least 75% of treated AK lesions) assessed at 12 weeks after last PDT.
Secondary	Change of Total Lesion Area 12 Weeks After Last PDT	12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT	The fifth key secondary efficacy variable in the hierarchic test procedure was the change from baseline in the total lesion area per patient assessed at 12 weeks after last PDT.
Secondary	Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 0 to 3	12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT	Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy. Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated). The outcome was calculated using a 5-point scale ranging from "very good" (0) to "impaired" (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened).
Secondary	Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 1 to 3	12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT	Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy. Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated). The outcome was calculated using a 5-point scale ranging from "very good" (0) to "impaired" (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened).
Other	Patient Recurrence Rate in Follow-up (Cumulative)	12 months after last treatment (PDT-1 or PDT-2, if re-treated)	Cumulative numbers of patients with complete response who showed recurrences 12 months after last treatment (PDT-1 or PDT-2, if re-treated). A patient with complete response was regarded as recurrent if at least one baseline AK lesion recurred during the follow-up (FU). Complete response was achieved if all treated lesions of the patient were cleared 12 weeks after the last treatment (PDT-1 or PDT-2, if re-treated). Lesions that showed recurrence at 6-months (FU1) were also defined as recurrent at 12-months follow-up (FU2).
Other	Lesion Recurrence Rate in Follow-up (Cumulative)	12 months after last treatment (PDT-1 or PDT-2, if retreated)	Cumulative recurrence rate in follow-up of baseline AK lesions that were cleared 12 weeks after the last treatment (PDT-1 or PDT-2, if re-treated) and recurred during 12 months follow-up. Lesions that showed recurrence at 6-months (FU1) were also defined as recurrent at 12-months follow-up (FU2).
Other	Skin Quality in Follow-up (6 Months)	6 months after last treatment (PDT-1 or PDT-2, if re-treated)	Frequency of skin quality changes in follow-up compared to baseline. Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the follow up visit (6 months) including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy. Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
Other	Skin Quality in Follow-up (12 Months)	12 months after last treatment (PDT-1 or PDT-2, if re-treated)	Frequency of skin quality changes in follow-up compared to baseline. Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the follow up visit (12 months) including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy. Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
Other	Patients' Satisfaction in Follow-up (6 Months)	6 months after last treatment (PDT-1 or PDT-2, if re-treated)	Patients' satisfaction of the overall cosmetic outcome was assessed at 6-months follow-up visit using a 5-point scale, where 0=very good, 1=good, 2=satisfactory, 3=unsatisfactory, and 4=impaired. The lowest rating is the best outcome, the highest rating is the worst outcome.
Other	Patients' Satisfaction in Follow-up (12 Months)	12 months after last treatment (PDT-1 or PDT-2, if re-treated)	Patients' satisfaction of the overall cosmetic outcome was assessed at 12-months follow-up visit using a 5-point scale, where 0=very good, 1=good, 2=satisfactory, 3=unsatisfactory, and 4=impaired. The lowest rating is the best outcome, the highest rating is the worst outcome.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

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ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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