Clinical trial · Interventional
Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery
A Phase 3b Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Imiquimod Cream Following Cryosurgery for the Treatment of Actinic Keratoses
NCT00894647CI-TRIAL-00003859completedPhase 3Results postedClinicalTrials.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)
The objective of this study is to evaluate the efficacy and safety of imiquimod cream versus placebo cream when used after cryosurgery in the treatment of actinic keratoses (AKs).
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 cream | Drug | Imiquimod | ALIAS |
| placebo cream | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- placebo cream in 250mg/packet, up to 2 packets applied daily
- interventionNames
- Drug: placebo cream
- type
- ACTIVE_COMPARATOR
- label
- imiquimod cream
- description
- Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
- interventionNames
- Drug: imiquimod cream
Primary outcomes (1)
- measure
- Change From Baseline in Percentage of Lesion Count
- timeFrame
- Week 26
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * In good general health * Negative urine pregnancy test (for women of child-bearing potential) and agree to use an approved method of birth control while enrolled in the study. * Prior to cryosurgery, have ≥ 10 clinically typical (visible or palpable) AKs in an area that exceeds 25 cm2 on the face. * Must have had cryosurgery on 5 to 14 AKs on the face after giving informed consent and prior to receiving study medication. Lesions previously treated with cryosurgery must be healed sufficiently prior to randomization to study cream. * Following cryosurgery, have ≥ 5 clinically typical (visible or palpable) AKs in an area that exceeds 25 cm2 on the face that are suitable for treatment with the study cream. Exclusion Criteria: * Women who are pregnant, lactating, or planning to become pregnant during the study * Had a medical event within 90 days of the visit (e.g., stroke, heart attack, etc.). * Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema). * Have received specific treatments/medications in the treatment area within the designated time period prior to study treatment initiation
References
Publications (0)
Data not yet available
No reference posted for this study.