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Immune Response Modifier

Open-Label Safety Study to Evaluate Imiquimod Cream, 5% for Large Areas of Actinic Keratosis

Phase 4
Waitlist Available
Research Sponsored by Graceway Pharmaceuticals, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 18
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

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 purpose of this study is to evaluate the safety of one, two, or three cycles of imiquimod for the treatment of AK. The AK lesions treated can be in adjacent and nonadjacent areas of the head, torso, and extremities. The total surface area for the AK lesions must be greater than 25 cm2. The secondary objective is to evaluate the effectiveness of treatment with imiquimod in people with large surface areas of AK.

Eligible Conditions
  • Keratoderma Blennorrhagicum
  • Earwax Impaction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants Who Experienced an Adverse Event
Secondary study objectives
Percent Reduction From Baseline to the Final Follow-up in Total Actinic Keratosis Lesion Count

Side effects data

From 2007 Phase 4 trial • 551 Patients • NCT00116649
30%
Actinic Keratosis
23%
Application site pruritus
15%
Squamous cell carcinoma
15%
Basal cell carcinoma
11%
Skin lesion
9%
Application site irritation
8%
Seborrhoeic Keratosis
6%
Skin Papilloma
6%
Fatigue
5%
Upper respiratory tract infection
5%
Application site pain
1%
Myocardial infarction
1%
Coronary artery disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aldara (Imiquimod) Cream

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Aldara 5%Experimental Treatment1 Intervention
Aldara® (imiquimod) cream, 5% supplied in 250 mg single-use packets.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imiquimod
FDA approved

Find a Location

Who is running the clinical trial?

Graceway Pharmaceuticals, LLCLead Sponsor
24 Previous Clinical Trials
3,831 Total Patients Enrolled
Sharon Levy, MDStudy DirectorGraceway Pharmaceuticals
2 Previous Clinical Trials
426 Total Patients Enrolled
~27 spots leftby Jan 2026
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