Actinic Keratosis Study
Information source: Washington University School of Medicine
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Actinic Keratosis
Intervention: 5-fluorouracil 5% cream (Drug); Calcipotriol 0.005% ointment (Drug); Vaseline (Drug)
Phase: Phase 0
Status: Recruiting
Sponsored by: Washington University School of Medicine Official(s) and/or principal investigator(s): Lynn Cornelius, MD, Principal Investigator, Affiliation: Washington University School of Medicine
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.
Clinical Details
Official title: The Role of Calcipotriol in Treatment of Pre-cancerous Skin Lesions
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: percentage of change in the number of actinic keratoses from baseline
Secondary outcome: complete and partial (>75%) clearance of actinic keratosesComposite score of erythema, itching and skin pain after topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone treatment of actinic keratoses Induction of TSLP expression in keratinocytes by calcipotriol differences in response to topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone between the four anatomical sites
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Washington University School of Medicine, Saint Louis, Missouri 63310, United States; Recruiting Mary Tabacchi, Phone: 314-362-8171, Email: mtabacch@wustl.edu Shawn Demehri, MD,PhD, Email: sdemehri@dom.wustl.edu Shawn Demehri, MD, PhD, Sub-Investigator
Additional Information
Starting date: October 2013
Last updated: December 17, 2013
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