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

NCT00294320 | Completed Phase 3

• 1 other identifier: 1517-IMIQ
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Actinic Keratosis

Keywords

Aldara; Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks after the end of treatment

Secondary Outcomes (1)

• To obtain histological confirmation of the diagnosis of the lesions demonstrated by biopsy.

  8 weeks after the end of treatment

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Aldara (Imiquimod)

2

PLACEBO COMPARATOR

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

Other: Vehicle cream

Interventions

Aldara (Imiquimod) DRUG

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

1

Vehicle cream OTHER

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MEDA Pharma GmbH & Co. KG: lead

Study Sites (1)

Hopital L'Archet 2

Nice, Cedex 3, France

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jean-Paul Ortonne, Professor

  CPCAD, Hopital L'Archet 2

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 21, 2006
• First Posted: February 22, 2006
• Study Start: February 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: February 7, 2022

Record last verified: 2008-09

Locations

FR (1)