Actinic Keratosis Study

Early Phase 1CompletedNCT02019355

Washington University School of Medicine132 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

132

Conditions

Actinic Keratosis

Interventions

5-fluorouracil 5% creamDRUG

Calcipotriol 0.005% ointmentDRUG

VaselineDRUG

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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 (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

percentage of change in the number of actinic keratoses from baseline

To compare the efficacy of topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone in treatment of actinic keratosis in patients with multiple actinic keratoses at each of the four anatomical sites (scalp, face, right upper extremity and left upper extremity). The outcome of interest is percentage change from baseline number of actinic keratoses in the target treatment area on scalp, face, right upper extremity and left upper extremity at 8 weeks after treatment.

Time frame: 8 weeks

Secondary Outcomes

complete and partial (>75%) clearance of actinic keratoses

o To determine complete and partial (\>75%) clearance of actinic keratoses at 8 weeks after treatment.

Time frame: 8wks

Composite score of erythema, itching and skin pain after topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone treatment of actinic keratoses

To determine the composite scores of erythema, itching and pain (determined using standardized scales) following topical application of 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone at the end of the 4-day treatment period.

Time frame: 4days

Induction of TSLP expression in keratinocytes by calcipotriol

To examine the induction of TSLP expression in keratinocytes by calcipotriol at the site of the actinic keratoses at the end of 4-day treatment of course.

Time frame: 4 days

differences in response to topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone between the four anatomical sites

To determine any differences in response to topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone between the four anatomical sites at 8 weeks after treatment.

Time frame: 8wks

Data from ClinicalTrials.gov

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