Phase 3
N=490
Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs)
Actinic Keratosis
Bottom Line
View on ClinicalTrials.gov: NCT00603798 ↗Enrolled (actual)
490
Serious AEs
3.7%
Results posted
Jun 2010
Primary outcome: Primary: Number of Participants With Complete Clearance of AK Lesions — 55; 41; 9 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Imiquimod cream (Drug); Placebo cream (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Graceway Pharmaceuticals, LLC
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Clearance of AK Lesions |
55; 41; 9 | — |
| SECONDARY Number of Participants With Partial Clearance of AK Lesions |
87; 70; 21 | — |
| SECONDARY Percent Change From Baseline in AK Lesion Count |
-80.0; -66.7; -23.6 | — |
| SECONDARY Local Skin Reactions (LSR) |
413.5; 372.0; 188.6 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00603798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.