Clinical trial · Interventional
Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions
Pilot Study to Evaluate Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions (Clinical and Sub-clinical), When Treated With Aldara 5% (Imiquimod) Cream
NCT00294320CI-TRIAL-00056349completedPhase 3ClinicalTrials.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 evaluate the performance of two techniques to monitor the clearance of AK lesions when treated with Aldara 5% cream.
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 |
|---|---|---|---|
| Aldara (Imiquimod) | Drug | Imiquimod | ALIAS |
| Vehicle cream | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- 250mg of Imiquimod cream application once daily 3 times per week.
- interventionNames
- Drug: Aldara (Imiquimod)
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- 250mg vehicle cream for application once daily 3 times per week.
- interventionNames
- Other: Vehicle cream
Primary outcomes (1)
- measure
- To compare the performance of two techniques to monitor the clearance of AK lesions (clinical and subclinical) when treated with Aldara 5% cream by comparison of lesion counts.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 5 clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions * Free of any significant findings (e.g tattoos) in the potential application site area. * Willing to discontinue sun-tanning and use of sunbed/sun parlour use * Willing to stop use of moisturisers, body oils, and over the counter retinol products or products containing alpha or beta hydroxyacids in the treatment or surrounding area. * Willing ot withhold sunscreen and/or moisturiser use for 24 hours prior to each clinical assessment Exclusion Criteria: * Evidence of unstable or uncontrolled clinically significant medical condition. * Any dermatological disease and or condition in the treatment of the surrounding area that may be exacerbated by treatment with imiquimod. * Currently participating in another clinical study or have completed another study within an investigational drug within the past 30 days. * Have active chemical dependency or alcoholism * Have know allergies to any excipient or study cream * Have received previous treatment with imiquimod for any indication within the treatment area. * Known to be affected by porphyria
References
Publications (0)
Data not yet available
No reference posted for this study.