Clinical trial · Interventional
Evaluation of a Topical Treatment for Actinic Keratosis
Phase 2 Double-blind, Randomized, Placebo-controlled, Parallel Group, Multi-center Study
NCT01921907CI-TRIAL-00017102completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A topical treatment applied twice daily for 4 weeks to induce disappearance of facial actinic keratosis (AK). First 4 weeks treatment (visit 1, 2 and 3 at 0,2 an 4 weeks) treated as a double blind parallel study. From weeks 4 to 7 (visit 3 to visit 4) all patients to be treated by the active component.
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 of Face and Scalp | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AD17137 topical treatment | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Active
- description
- topical treatment
- interventionNames
- Drug: AD17137 topical treatment
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- topical treatment
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Complete Clearance (100% of AK lesions) from baseline (Visit 1) to Visits 3 and 4. Complete Clearance (100% of AK lesions) from baseline (Visit 1) to Visits 3 and 4.
- timeFrame
- baseline to Week 7
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Males or females 30 to 90 years old, inclusive, in good general health * Clinical diagnosis of Actinic Keratosis * At least 2 clinically diagnosed, 3-15 mm AK lesions on face or scalp * Patient is competent to understand and sign a consent form, and is willing and able to follow study procedures and attend all visits * Female patients of childbearing potential must have a negative urine pregnancy test prior to receiving study medication * Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception * Pharmacologic methods of contraception should be stable for 1 month prior to Visit 1 and be maintained at same dose during the study Exclusion Criteria: * Patients who had been treated with: 5-FU, diclofenac, retinoids, ingenol mebutate or imiquimod within 4 weeks of study, immunomodulators, or interferon/interferon inducers or systemic immunosuppressants within 8 weeks of study, cryodestruction, curettage, photodynamic therapy, surgical excision on the treatment area within 4 weeks of study, systemic cancer therapy, UVA therapy, UVB therapy, laser abrasion, dermabrasion * History of hereditary angio-edema, Epilepsy or Parkinson's Disease * Erythroderma or history of immunodeficiency disorders * Pregnancy, lactation or patient who is not practicing effective contraception * History of alcohol and drug abuse within 5 years of screening * Known hypersensitivity or previous allergic reaction to any of the components of the study medication * Having a member of the same household in the trial * Patient has participated in an investigational clinical, surgical, drug or device study within the past 30 days * Patients who in the opinion of the investigator should not be included in the study for any reason, including inability to follow procedures
References
Publications (0)
Data not yet available
No reference posted for this study.