Clinical trial · Interventional
Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs)
A Phase 3, Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of Six Weeks of Treatment With Imiquimod Creams for Actinic Keratoses
- 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 whether imiquimod creams are effective in treating Actinic Keratoses when applied to the face or balding scalp. Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient contained in the study cream for this study is the same as that of the approved product Aldara, which has shown to be safe and effective for the treatment of 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 (3)
- type
- ACTIVE_COMPARATOR
- label
- 3.75% imiquimod cream
- interventionNames
- Drug: Imiquimod cream
- type
- ACTIVE_COMPARATOR
- label
- 2.5% imiquimod cream
- interventionNames
- Drug: Imiquimod cream
- type
- PLACEBO_COMPARATOR
- label
- Placebo cream
- interventionNames
- Drug: Placebo cream
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * In good general health. * Have 5 to 20 AKs on the face or balding scalp. * Negative pregnancy test (for women who are able to become pregnant). * Willing to make frequent visits to the study center during the treatment and follow-up periods. Exclusion Criteria: * Women who are pregnant, lactating or planning to become pregnant during the study. * Have had a medical event within 90 days of the first visit (such as: stroke, heart attack). * Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (such as: rosacea, psoriasis, atopic dermatitis, eczema). * Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.
References
Publications (1)
- BACKGROUNDHanke CW, Beer KR, Stockfleth E, Wu J, Rosen T, Levy S. Imiquimod 2.5% and 3.75% for the treatment of actinic keratoses: results of two placebo-controlled studies of daily application to the face and balding scalp for two 3-week cycles. J Am Acad Dermatol. 2010 Apr;62(4):573-81. doi: 10.1016/j.jaad.2009.06.020. Epub 2010 Feb 4. PMID 20133012