Actinic Keratosis MedDRA version: 14.1 Level: PT Classification code 10000614 Term: Actinic keratosis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Product Name: Resiquimod Gel
Pharmaceutical Form: Gel
Sponsors
Spirig Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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 |
|---|---|
| Main Objective: The primary objective of this extension trial is to determine the recurrence rate of 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. The recurrence rate will be determined at the same treatment area where trial medications were administered in the previous trial (treated 25 cm2 area) and if possible per treatment group as assigned in trial SP848-AK-1101.;Secondary Objective: For patients with complete clinical clearance: • Follow-up of unresolved adverse and serious adverse events occurred in the previous trial SP848-AK-1101 until resolution. • Follow-up of unresolved abnormal laboratory values occurred in the previous trial SP848-AK-1101 until resolution. • Newly occurred dermal adverse and serious adverse events on the previous treatment area. For Non-Responders: • Follow-up of AK-lesions (existing lesions, new lesions, changes) • Follow-up of non-resolved adverse and serious adverse events occurred in the previous trial SP848-AK-1101 until resolution. • Follow-up of unresolved abnormal laboratory values occurred in the previous trial SP848-AK-1101 until resolution. • Newly occurred dermal adverse and serious adverse events on the previous treatment area.;Primary end point(s): Efficacy For patients with complete clinical clearance: • 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.;Timepoint(s) of evaluation of this end point: 6 and 12 months after the end of trial SP848-AK-1101 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: For patients with complete clinical clearance: • Occurrence of new AK-lesions within the former treatment area. For Non-Responders: • Monitoring of AK-lesions on the former treatment area. Safety: For patients with complete clinical clearance and for Non-Responders: • Number of newly occurred dermal adverse and serious adverse events on the previous treatment area (local tolerability).;Timepoint(s) of evaluation of this end point: ongoing | — |
Countries
Germany, Switzerland
Contacts
Public ContactInfo Contact
Spirig Pharma AG
Outcome results
None listed