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

NCT01203878 | Terminated Phase 4 Results

• 1 other identifier: 09US05N375-Gold
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

Brief 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

Conditions

Actinic Keratosis

Keywords

Imiquimod; Photodynamic therapy; Actinic keratoses; Sequential therapy; Therapeutic uses

Outcome Measures

Primary Outcomes (1)

• Actinic Keratosis Count

  The percent change in actinic keratosis count as compared to the baseline lesion count

  Week 18 (4 weeks after randomization visit)

Secondary Outcomes (2)

• Complete Clearance

  Week 18 (4 weeks after randomization visit)

• Cosmetic Appearance

  Week 18 (4 weeks after randomization visit)

Study Arms (2)

Imiquimod & photodynamic therapy

EXPERIMENTAL

Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light

Drug: Photodynamic therapy; Drug: Imiquimod

Imiquimod

ACTIVE COMPARATOR

Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation

Drug: Imiquimod

Interventions

Photodynamic therapy DRUG

Administered 4 weeks after completion of imiquimod therapy

Also known as: Levulan Kerasticks (aminolevulinic acid 20% solution)

Imiquimod & photodynamic therapy

Imiquimod DRUG

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

Also known as: Zyclara (imiquimod 3.75% cream)

Imiquimod; Imiquimod & photodynamic therapy

Eligibility Criteria

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

You may qualify if:

• Male and female adults; 18 and over
• At least 10 and no more than 30 clinically typical actinic keratoses on the face

You may not qualify if:

• 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

Sponsors & Collaborators

• Tennessee Clinical Research Center: lead
• Graceway Pharmaceuticals, LLC: collaborator

Study Sites (3)

AboutSkin Dermatology and DermSurgery, PC

Englewood, Colorado, 80113, United States

Location

Dermatology, Laser & Vein Specialists of the Carolinas

Charlotte, North Carolina, 28207, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Photochemotherapy; Aminolevulinic Acid; Solutions; Imiquimod

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Early termination (slow enrollment) leading to small numbers of subjects analyzed; missing measurement(s) on a patient

Results Point of Contact

• Title: Medical Director
• Organization: Tennessee Clinical Research Center

jbiron@tnclinicalresearch.com

615-383-2400

Study Officials

• Michael Gold, MD

  Tennessee Clinical Research Center

  STUDY CHAIR

• Joel Cohen, MD

  AboutSkin Dermatology and DermSurgery, PC

  PRINCIPAL INVESTIGATOR

• Girish Munavalli, MD

  Dermatology, Laser & Vein Specialists of the Carolinas

  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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 17, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: December 8, 2014
• Results First Posted: November 20, 2014

Record last verified: 2014-11

Locations

US (3)