Clinical trial · Interventional
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
An Exploratory, Open-label Study of Sequential Field-directed Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
NCT01203878CI-TRIAL-00016277terminatedPhase 4Results 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): Unable to reach target enrollment of 60 subjects
Summary
Brief summary (as posted)
The purpose of this study is to explore the effect of treating actinic keratoses of the face with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with imiquimod alone
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Imiquimod | Drug | Imiquimod | ALIAS |
| Photodynamic therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Imiquimod & photodynamic therapy
- description
- Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
- interventionNames
- Drug: Photodynamic therapy
- Drug: Imiquimod
- type
- ACTIVE_COMPARATOR
- label
- Imiquimod
- description
- Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
- interventionNames
- Drug: Imiquimod
Primary outcomes (1)
- measure
- Actinic Keratosis Count
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female adults; 18 and over * At least 10 and no more than 30 clinically typical actinic keratoses on the face Exclusion Criteria: * Hypertrophic actinic keratoses or other skin lesions on the head that might required excluded treatment during the study * Known contraindication to treatment with imiquimod or photodynamic therapy * Condition that would limit compliance, be a potential safety risk, or require therapy with an excluded treatment * Systemically immunocompromised * Pregnant or nursing * Dermatologic disease and/or condition in treatment area that might exacerbated by treatment with imiquimod, cause difficulty with examination, or require therapy with an excluded treatment * Participation in another clinical study * Treatment within the past 60 days with: * Ultraviolet therapy * Systemic immunomodulators * Chemotherapeutic or cytotoxic agents * Investigational agents * Treatment on the head within the past 60 days with: * Imiquimod * Photodynamic therapy * Red or blue light source therapy * Cryotherapy or chemotherapy * Surgical excision or curettage * Topical corticosteroids * Laser * Dermabrasion * Chemical peel * Topical retinoids * Topical 5-fluorouracil * Topical pimecrolimus or tacrolimus * Topical diclofenac * Treatment for actinic keratoses on the head within the past 60 days
References
Publications (0)
Data not yet available
No reference posted for this study.