Clinical trial · Interventional
Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses
A Randomized, Open-label, Assessor-blinded, Split-face Study of Imiquimod 5% Cream Applied After Cryotherapy of Actinic Keratoses
NCT00774787CI-TRIAL-00024729completedPhase 4Results 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 purpose of this study is to determine if use of topical imiquimod cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) at 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 Keratoses | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| imiquimod 5% cream | Drug | Imiquimod | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Imiquimod, treatment, topical cream
- description
- Imiquimod 5% cream, 1 packet (250 mg cream), applied to left or right treatment area on the face and/or balding scalp
- interventionNames
- Drug: imiquimod 5% cream
- type
- NO_INTERVENTION
- label
- Control, Untreated
- description
- No treatment of treatment area on the other half of the face and/or balding scalp
Primary outcomes (1)
- measure
- Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment
- timeFrame
- Baseline, 4-8 weeks post-treatment
- description
- Percent change = \[(actinic keratoses count at 4-8 weeks post-treatment)-(actinic keratoses count at baseline)\]/(actinic keratoses count at baseline)\]\*100%. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * A clinical diagnosis of actinic keratoses * Actinic keratoses in two reasonably bilaterally symmetric areas on the face and/or balding scalp: * each area with a minimum of 25 cm\^2 and a maximum of 50 cm\^2 * each area with at least 6 typical, non-hypertrophic target AKs * with target AK lesion counts of +/- 1 lesion between the areas * each area that the patient can distinguish with respect to study drug application * Able to comply with all study requirements * Are willing and able to give written informed consent Exclusion Criteria: * Uncontrolled intercurrent or chronic illness * Systemic immunocompromise due to disease or treatment * Clinically relevant systemic autoimmune disease * Pregnant or nursing * Dermatologic disease and/or condition in the treatment area that may be exacerbated by imiquimod or cause difficulty with examination * Participation in another clinical study * Allergies to imiquimod or any of the excipients in the cream * Treatment within the past 90 days with any of the following: * Psoralens plus ultraviolet A therapy * Ultraviolet B therapy * Systemic immunomodulators (e.g. oral or parenteral corticosteroids at greater than physiologic doses, interferons, anti-TNF agents, cytokines) * Chemotherapeutic or cytotoxic agents; * Investigational agent * Treatment within the past 30 days with any of the following: * Surgical excision * Photodynamic therapy * Curettage * Topical corticosteroids * Laser * Dermabrasion * Chemical peel * Imiquimod 5% cream * Topical retinoids * 5-fluorouracil * Masoprocol * Pimecrolimus or tacrolimus
References
Publications (0)
Data not yet available
No reference posted for this study.