Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy

Actinic Keratosis Clinical Trial

Official title:

An Exploratory, Open-label Study of Sequential Field-directed Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01203878
• Other study ID #: 09US05N375-Gold
• Status: Terminated
• Phase: Phase 4
• First received: September 15, 2010
• Last updated: November 20, 2014
• Start date: September 2010
• Est. completion date: November 2011

Study information

• Verified date: November 2014
• Source: Tennessee Clinical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the effect of treating actinic keratoses of the face with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with imiquimod alone

Description:

Actinic keratoses are common skin lesions associated with solar ultraviolet radiation exposure. Some actinic keratoses may develop into skin cancers.

Imiquimod 3.75% cream is an approved treatment for actinic keratoses that utilizes a regimen of application to the entire face or balding scalp of up to 2 packets of cream daily for two 2-week cycles, separated by a 2-week no treatment interval.

Photodynamic therapy with aminolevulinic acid (ALA) 20% topical solution is also an approved treatment for actinic keratoses. ALA is applied to actinic keratoses, and after an incubation period, is excited with light. Although approved as a lesion-directed treatment for actinic keratoses, treatment of a field (e.g. face) with photodynamic therapy is commonly performed.

Treatment with photodynamic therapy followed by imiquimod 5% cream has been reported in patients with actinic keratoses, basal cell carcinoma and Bowen's disease, and treatment with imiquimod 5% cream followed by photodynamic therapy in patients with vulvar intraepithelial neoplasia. There are, however, no prior studies on the safety and/or efficacy of using topical imiquimod 3.75% in conjunction with photodynamic therapy in the treatment of actinic keratoses.

This study will use an open-label parallel cohort design in which all patients will received treatment with imiquimod 3.75% cream, and subsequently will be randomized to either photodynamic therapy or observation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male and female adults; 18 and over

• At least 10 and no more than 30 clinically typical actinic keratoses on the face

Exclusion Criteria:

• Hypertrophic actinic keratoses or other skin lesions on the head that might required excluded treatment during the study

• Known contraindication to treatment with imiquimod or photodynamic therapy

• Condition that would limit compliance, be a potential safety risk, or require therapy with an excluded treatment

• Systemically immunocompromised

• Pregnant or nursing

• Dermatologic disease and/or condition in treatment area that might exacerbated by treatment with imiquimod, cause difficulty with examination, or require therapy with an excluded treatment

• Participation in another clinical study

• Treatment within the past 60 days with:

• Ultraviolet therapy

• Systemic immunomodulators

• Chemotherapeutic or cytotoxic agents

• Investigational agents

• Treatment on the head within the past 60 days with:

• Imiquimod

• Photodynamic therapy

• Red or blue light source therapy

• Cryotherapy or chemotherapy

• Surgical excision or curettage

• Topical corticosteroids

• Laser

• Dermabrasion

• Chemical peel

• Topical retinoids

• Topical 5-fluorouracil

• Topical pimecrolimus or tacrolimus

• Topical diclofenac

• Treatment for actinic keratoses on the head within the past 60 days

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Photodynamic therapy
Administered 4 weeks after completion of imiquimod therapy
• Imiquimod
Imiquimod 3.75% cream, up to 2 packets, applied topically daily for two 2-week cycles separated by a no-treatment interval of 2-weeks, followed observation

Locations

Country	Name	City	State
United States	Dermatology, Laser & Vein Specialists of the Carolinas	Charlotte	North Carolina
United States	AboutSkin Dermatology and DermSurgery, PC	Englewood	Colorado
United States	Tennessee Clinical Research Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Tennessee Clinical Research Center	Graceway Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actinic Keratosis Count	The percent change in actinic keratosis count as compared to the baseline lesion count	Week 18 (4 weeks after randomization visit)	No
Secondary	Complete Clearance	The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face).	Week 18 (4 weeks after randomization visit)	No
Secondary	Cosmetic Appearance	Change (improvement) in investigator scores of cosmetic appearance of the treatment area (entire face) by objective and subjective assessments: INVESTIGATOR COSMETIC ASSESSMENT 0 - Facial skin is smooth to the touch, without significant lines or unevenness in pigmentation; 1 - Facial skin shows 1 area (cheeks, forehead, or the perioral area) of significant 3 - Facial skin shows 3 areas with significant roughness, dyspigmentation, or fine lines 2 - Facial skin shows 2 areas of significant roughness, dyspigmentation, or fine lines 4 - All are severe in severity	Week 18 (4 weeks after randomization visit)	No