Evaluation of Two Different Non-invasive Techniques to Monitor the Clearance of Actinic Keratosis Lesions

Meda Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Actinic Keratosis

Treatments: Other: Vehicle cream; Drug: Aldara (Imiquimod)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00294320

1517-IMIQ

Details and patient eligibility

About

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.

Full description

Each technique will be assessed by comparison of lesion counts (clinical and sub-clinical) revealed by the techniques, at start and end of the study and those demonstrated during treatment. In addition a qualitative assessment of each technique will be made for performance and ease of use.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

12 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

250mg of Imiquimod cream application once daily 3 times per week.

Treatment:

Drug: Aldara (Imiquimod)

2

Placebo Comparator group

Description:

250mg vehicle cream for application once daily 3 times per week.

Treatment:

Other: Vehicle cream