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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


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 keratoses

Composite 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


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 20, 2015

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