Actinic Keratosis Study



Status:Completed
Conditions:Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:50 - Any
Updated:5/20/2016
Start Date:October 2013
End Date:March 2015

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The Role of Calcipotriol in Treatment of Pre-cancerous Skin Lesions

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.


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
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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mi
from
Saint Louis, MO
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