Clinical trial · Observational
Observational Trial Tolerability and Efficacy of Resiquimod Gel in Patients Treated for Actinic Keratosis.
Observational (Non-interventional), Follow-up Trial Assessing Long-term Local Tolerability and Efficacy (Recurrence Rate) of Resiquimod Gel in Patients Treated for Actinic Keratosis.
NCT01806961CI-TRIAL-00023356terminatedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): sponsor decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- clearance at end of trial SP848-AK-1101
- description
- no trial medication during this follow-up trial
Primary outcomes (1)
- measure
- Determine the Recurrence Rate of AK-lesions
- timeFrame
- at 6 and 12 months
- description
- 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 outcomes (2)
- measure
- Follow-up of AK-lesions (Existing Lesions, New Lesions, Changes)
- timeFrame
- at 6 and 12 months
- description
- clinical examination
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.