Clinical trial NCT02019355: Actinic Keratosis Study
Official title: The Role of Calcipotriol in Treatment of Pre-cancerous Skin Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Actinic Keratosis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 132
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: percentage of change in the number of actinic keratoses from baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: complete and partial (>75%) clearance of actinic keratoses
timeFrame: 8wks
measure: Composite score of erythema, itching and skin pain after topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone treatment of actinic keratoses
timeFrame: 4days
measure: Induction of TSLP expression in keratinocytes by calcipotriol
timeFrame: 4 days
measure: differences in response to topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone between the four anatomical sites
timeFrame: 8wks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Lynn Cornelius, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cunningham TJ, Tabacchi M, Eliane JP, Tuchayi SM, Manivasagam S, Mirzaalian H, Turkoz A, Kopan R, Schaffer A, Saavedra AP, Wallendorf M, Cornelius LA, Demehri S. Randomized trial of calcipotriol combined with 5-fluorouracil for skin cancer precursor immunotherapy. J Clin Invest. 2017 Jan 3;127(1):106-116. doi: 10.1172/JCI89820. Epub 2016 Nov 21.