Actinic Keratosis
Conditions
Brief summary
Determine the recurrence rate of actinic keratosis (AK) lesions in patients with complete clinical clearance at the end of the previous trial SP848-AK-1101 at 6 and 12 months of follow-up.
Detailed description
Efficacy Evaluation: • Primarily based on clinical inspection of the former 25 cm2 treatment area and count of the AK-lesions. Safety Evaluation: * Evaluation of adverse events (AEs) and serious adverse events (SAEs) * Evaluation of newly occurred dermal adverse events (AEs) and serious adverse events (SAEs) in the previous treatment area at 6 months and 12 months of follow-up (local tolerability). * Follow-up of unresolved adverse and serious adverse events that occurred in the previous trial SP848-AK-1101. * Follow-up of unresolved abnormal laboratory values that occurred in the previous trial SP848-AK-1101.
Interventions
None listed
Sponsors
Spirig Pharma Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent. * Participation in the previous clinical trial SP848-AK-1101. * Patient with complete clinical clearance (i.e. no previously existing AK-lesion present) at the end of the trial SP848-AK-1101 or Non-Responder who withdrew from the trial prematurely.
Exclusion criteria
* Evidence of unstable or uncontrolled clinically significant medical conditions as determined by the investigator (e.g., cardiovascular, immunological, hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, infectious, gastrointestinal abnormalities or diseases). * Evidence of systemic cancer. * Dermatological disease or condition in the former treatment or surrounding area that might impair trial assessments (e.g., rosacea, atopic dermatitis, eczema) as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Recurrence Rate of AK-lesions | at 6 and 12 months | Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes) | at 6 and 12 months | clinical examination |
| Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area | at 6 and 12 months | recording of adverse events |
Countries
Germany, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clearance at End of Trial SP848-AK-1101 no trial medication during this follow-up trial | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | sponsor decision | 16 |
Baseline characteristics
| Characteristic | Clearance at End of Trial SP848-AK-1101 |
|---|---|
| Age, Continuous | 73 years |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 16 |
| serious Total, serious adverse events | 1 / 16 |
Outcome results
Primary
Determine the Recurrence Rate of AK-lesions
Number of patients with persistent complete clearance at 6 and 12 months follow-up. Recurrence rate is to be determined at the same treatment area where the investigational medicinal products were administered in the previous trial.
Time frame: at 6 and 12 months
Population: No subject was analysed due to premature study termination (sponsor's decision) therefore no data was available for analysis
Secondary
Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)
clinical examination
Time frame: at 6 and 12 months
Secondary
Number of Newly Occurred Dermal Adverse and Serious Adverse Events on the Previous Treatment Area
recording of adverse events
Time frame: at 6 and 12 months