Actinic Keratosis Study (AK)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Lynn Cornelius, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02019355
First received: December 10, 2013
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

The main purpose of this study is to determine the effectiveness of a new combination therapy for actinic keratosis. This study investigates a new indication for an FDA-approved topical medication, calcipotriol, for treatment of actinic keratosis, including how well it works and how safe it is when used in combination with the standard of care medication (5-fluorouracil) for the skin condition.


Condition Intervention Phase
Actinic Keratosis
Drug: 5-fluorouracil 5% cream
Drug: Calcipotriol 0.005% ointment
Drug: Vaseline
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Calcipotriol in Treatment of Pre-cancerous Skin Lesions

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • percentage of change in the number of actinic keratoses from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To compare the efficacy of topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone in treatment of actinic keratosis in patients with multiple actinic keratoses at each of the four anatomical sites (scalp, face, right upper extremity and left upper extremity). The outcome of interest is percentage change from baseline number of actinic keratoses in the target treatment area on scalp, face, right upper extremity and left upper extremity at 8 weeks after treatment.


Secondary Outcome Measures:
  • complete and partial (>75%) clearance of actinic keratoses [ Time Frame: 8wks ] [ Designated as safety issue: No ]
    o To determine complete and partial (>75%) clearance of actinic keratoses at 8 weeks after treatment.

  • Composite score of erythema, itching and skin pain after topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone treatment of actinic keratoses [ Time Frame: 4days ] [ Designated as safety issue: Yes ]
    To determine the composite scores of erythema, itching and pain (determined using standardized scales) following topical application of 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone at the end of the 4-day treatment period.

  • Induction of TSLP expression in keratinocytes by calcipotriol [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    To examine the induction of TSLP expression in keratinocytes by calcipotriol at the site of the actinic keratoses at the end of 4-day treatment of course.

  • differences in response to topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone between the four anatomical sites [ Time Frame: 8wks ] [ Designated as safety issue: No ]
    To determine any differences in response to topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone between the four anatomical sites at 8 weeks after treatment.


Estimated Enrollment: 160
Study Start Date: October 2013
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: calcipotriol plus 5-fluorouracil
calcipotriol 0.005% ointment and 5-fluorouracil 5% cream are mixed at 1:1 weight ratio. The compounded medication is applied topically twice a day for 4 days.
Drug: 5-fluorouracil 5% cream
Other Name: Efudex
Drug: Calcipotriol 0.005% ointment
Other Names:
  • Calcipotriene
  • Dovonex
  • MC 903
Active Comparator: 5-fluorouracil plus vaseline
5-fluorouracil 5% cream and vaseline are mixed at 1:1 weight ratio. The compounded medication is applied topically twice a day for 4 days.
Drug: 5-fluorouracil 5% cream
Other Name: Efudex
Drug: Vaseline

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age of at least 50 years
  • Presence of four to fifteen clinically typical, visible, and discrete actinic keratoses in 25 cm2 on any of the four anatomical sites: scalp, face, right upper extremity and left upper extremity
  • Ability and willingness of the patient to participate in the study (Informed consent is obtained)

Exclusion Criteria:

  • Treatment area is within 5 cm of an incompletely healed wound or a suspected basal-cell or squamous-cell carcinoma
  • Treatment area contained hypertrophic and hyperkeratotic lesions, cutaneous horns, or lesions that had not responded to repeated cryotherapy
  • Recent (within a month) use of medications that could interfere with evaluation of the treatment area (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet B phototherapy, other therapies for actinic keratoses, or oral retinoids)
  • Premenopausal Women (to avoid any risk of pregnancy)
  • History of hypercalcemia or clinical evidence of vitamin D toxicity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019355

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63310
Contact: Mary Tabacchi    314-362-8171    mtabacch@wustl.edu   
Contact: Shawn Demehri, MD,PhD       sdemehri@dom.wustl.edu   
Sub-Investigator: Shawn Demehri, MD, PhD         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Lynn Cornelius, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Lynn Cornelius, MD, Chief, Division of Dermatology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02019355     History of Changes
Other Study ID Numbers: 201303070
Study First Received: December 10, 2013
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Fluorouracil
Calcipotriene
Petrolatum
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents
Emollients

ClinicalTrials.gov processed this record on September 15, 2014