Actinic Keratosis Study
Completed · Early Phase 1
Conditions studied: Actinic Keratosis
In brief
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.
Key facts
- Study ID
- NCT02019355
- Run by
- Washington University School of Medicine
- People needed
- 132
- Starts
- 2013-10-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2016-05-19
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Washington University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.