Topical Imiquimod Cream in Combination With Cryotherapy for the Treatment of Actinic Keratoses

NCT00774787 | Completed Phase 4 Results

• 1 other identifier: 08US02IMIQ-Rigel
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to determine if use of topical imiquimod cream after cryotherapy of actinic keratoses reduces the total number of lesions (those treated with cryotherapy and new ones) at follow-up.

Conditions

Actinic Keratoses

Keywords

Combination treatment; Imiquimod; Cryotherapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Actinic Keratoses Count at 4-8 Weeks Post-treatment

  Percent change = \[(actinic keratoses count at 4-8 weeks post-treatment)-(actinic keratoses count at baseline)\]/(actinic keratoses count at baseline)\]\*100%. Data from one patient, lost to follow-up immediately after cryotherapy, not included in these analyses. Actinic keratoses at 4-8 weeks post-treatment visit includes all actinic keratoses in each respective treatment area, baseline and new.

  Baseline, 4-8 weeks post-treatment

Secondary Outcomes (1)

• Cosmetic Appearance Score at 4-8 Weeks Post-treatment

  4-8 weeks post-treatment

Other Outcomes (1)

• Local Skin Reactions

  Post baseline to end of study (4-8 weeks post-treatment)

Study Arms (2)

Imiquimod, treatment, topical cream

EXPERIMENTAL

Imiquimod 5% cream, 1 packet (250 mg cream), applied to left or right treatment area on the face and/or balding scalp

Drug: imiquimod 5% cream

Control, Untreated

NO INTERVENTION

No treatment of treatment area on the other half of the face and/or balding scalp

Interventions

imiquimod 5% cream DRUG

1 packet (250 mg cream) 3 times per week for 4 weeks

Also known as: Aldara

Imiquimod, treatment, topical cream

Eligibility Criteria

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

You may qualify if:

• A clinical diagnosis of actinic keratoses
• Actinic keratoses in two reasonably bilaterally symmetric areas on the face and/or balding scalp:
• each area with a minimum of 25 cm\^2 and a maximum of 50 cm\^2
• each area with at least 6 typical, non-hypertrophic target AKs
• with target AK lesion counts of +/- 1 lesion between the areas
• each area that the patient can distinguish with respect to study drug application
• Able to comply with all study requirements
• Are willing and able to give written informed consent

You may not qualify if:

• Uncontrolled intercurrent or chronic illness
• Systemic immunocompromise due to disease or treatment
• Clinically relevant systemic autoimmune disease
• Pregnant or nursing
• Dermatologic disease and/or condition in the treatment area that may be exacerbated by imiquimod or cause difficulty with examination
• Participation in another clinical study
• Allergies to imiquimod or any of the excipients in the cream
• Treatment within the past 90 days with any of the following:
• Psoralens plus ultraviolet A therapy
• Ultraviolet B therapy
• Systemic immunomodulators (e.g. oral or parenteral corticosteroids at greater than physiologic doses, interferons, anti-TNF agents, cytokines)
• Chemotherapeutic or cytotoxic agents;
• Investigational agent
• Treatment within the past 30 days with any of the following:
• Surgical excision

Sponsors & Collaborators

• Rigel Dermatology: lead

Study Sites (3)

Spencer Dermatology and Skin Surgery

St. Petersburg, Florida, 33716, United States

Location

James Del Rosso

Henderson, Nevada, 89129, United States

Location

Rigel Dermatology

New York, New York, 10016, United States

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

Limitations and Caveats

Open label; small patient number; planned secondary endpoint of change in only lesions treated with cryotherapy (baseline) not determinable as only all lesions (baseline + new) consistently captured.

Results Point of Contact

• Title: Darrell Rigel
• Organization: Rigel Dermatology

dsrigel@prodigy.net

212-684-5964

Study Officials

• Darrell S Rigel, MD

  Rigel Dermatology

  STUDY CHAIR

• James Q Del Rosso, DO

  Private Practice

  PRINCIPAL INVESTIGATOR

• James Spencer

  Spencer Dermatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 17, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: November 7, 2016
• Results First Posted: October 27, 2010

Record last verified: 2016-10

Locations

US (3)