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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Outcome 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.

Outcome Time Frame:

8 weeks after the end of treatment

Safety Issue:

Yes

Principal Investigator

Jean-Paul Ortonne, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

CPCAD, Hopital L'Archet 2

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

1517-IMIQ

NCT ID:

NCT00294320

Start Date:

February 2006

Completion Date:

January 2007

Related Keywords:

  • Actinic Keratosis
  • Aldara
  • Actinic Keratosis
  • Keratosis
  • Keratosis, Actinic

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