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Trial record 1 of 2 for:    NCT02019355
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Actinic Keratosis Study (AK)

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ClinicalTrials.gov Identifier: NCT02019355
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Lynn Cornelius, MD, Washington University School of Medicine

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Actinic Keratosis Drug: 5-fluorouracil 5% cream Drug: Calcipotriol 0.005% ointment Drug: Vaseline Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Role of Calcipotriol in Treatment of Pre-cancerous Skin Lesions
Study Start Date : October 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. percentage of change in the number of actinic keratoses from baseline [ Time Frame: 8 weeks ]
    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 :
  1. complete and partial (>75%) clearance of actinic keratoses [ Time Frame: 8wks ]
    o To determine complete and partial (>75%) clearance of actinic keratoses at 8 weeks after treatment.

  2. Composite score of erythema, itching and skin pain after topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone treatment of actinic keratoses [ Time Frame: 4days ]
    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.

  3. Induction of TSLP expression in keratinocytes by calcipotriol [ Time Frame: 4 days ]
    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.

  4. differences in response to topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone between the four anatomical sites [ Time Frame: 8wks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019355


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63310
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Lynn Cornelius, MD Washington University School of Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lynn Cornelius, MD, Chief, Division of Dermatology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02019355    
Other Study ID Numbers: 201303070
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: December 2013
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Fluorouracil
Calcipotriene
Petrolatum
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents
Emollients